BAUSCH LOMB Accommodating Posterior Chamber Intraocular Lens User Guide

BAUSCH LOMB Accommodating Posterior Chamber Intraocular Lens

PHYSICIAN LABELING

DEVICE DESCRIPTION

The Bausch + Lomb Crystalens® Accommodating Posterior Chamber Intraocular Lens is a modified plate haptic lens with hinges across the plates adjacent to the optic.

INDICATIONS FOR USE

Crystalens® is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia. Crystalens® provides approximately one diopter of monocular accommodation which allows for near, intermediate, and distance vision without spectacles.

WARNINGS

1. Some patients may still require glasses to perform certain tasks.

2. There is no clinical data to support placing this lens in the ciliary sulcus.

3. The safety and effectiveness of this lens have not been evaluated in patients under 50 years of age.

4. The effect of vitrectomy on accommodation is unknown.

5. Small amounts of lens decentration occurring with an IOL having a narrow or small optic (< 5.5 mm) may cause glare or other visual disturbances under certain lighting conditions. Surgeons should consider this potential complication before implanting an IOL with a small or narrow optic. This lens incorporates a 5.0 mm optic.

6. YAG-laser posterior capsulotomies should be delayed until at least 12 weeks after the implant surgery. The posterior capsulotomy opening should be limited to no more than 4 mm. Consistent with other IOLS, there is an increased risk of lens dislocation and/or secondary surgical re-intervention with early or large YAG capsulotomies.

7. Crystalens® should not be implanted if the capsular bag is not intact or if there is any zonular rupture.

8. The safety and effectiveness of the device has not been established in patients with the following ocular conditions:
   a. Chronic drug miosis
   b. Amblyopia
   c. Diabetic retinopathy
   d. Previous corneal transplant
   e. History of retinal detachment
   f. Congenital bilateral cataracts
   g. Recurrent anterior or posterior segment inflammation of unknown etiology, or any disease producing an inflammatory reaction in the eye
   h. Patients in whom the intraocular lens may interfere with the ability to observe, diagnose or treat posterior segment diseases
   i. Surgical difficulties at the time of intraocular lens implantation which might increase the potential for complications (e.g., persistent bleeding, significant vitreous prolapse or loss)
   j. Corneal endothelial dystrophy
   k. Pseudo exfoliation syndrome
   I. Suspected microbial infection

9. Surgeons considering lens implantation in such patients should explore the potential risk/benefit ratio.

10. Mechanical hinge testing has been evaluated in a laboratory setting. Hinge movements of 1,000,000 cycles at 10 cycles per second have been documented with no degradation of hinge integrity or stability. However, long-term stability in the human eye has not been established. Therefore, surgeons should continue to monitor implant patients postoperatively on a regular basis.

11. The effectiveness of ultraviolet light absorbing lenses in reducing the incidence of retinal disorders has not been established.

12. The rate of cystoid macular edema may increase with sulcus-bag placement of the haptics.

13. Do not implant this lens in the anterior chamber or sulcus.

14. Unlike most other IOLs, the Crystallin’s optic has hinges connecting it to the haptic. There are adverse events in which the optic becomes stuck in an anterior, posterior, and/or tilted (asymmetric) position and the hinges become fixed in a displaced configuration. These events are referred to as cases of “lens vault” or “vaulting” and typically cause blurry vision and unexpected myopia, hyperopia, and/or astigmatism, and possibly higher order aberrations. When vaulting occurs, secondary surgery is often required to restore the correct optic position or sometimes to remove the lens. The following are important considerations:
    a. Vaulting is sometimes associated with excessive postoperative capsular fibrosis. Consider surgical techniques and medication to minimize this possibility. Carefully monitor patients postoperatively to ensure control of inflammation and implementing an appropriate follow-up schedule to detect early signs of excessive capsular fibrosis.
    b. Ensure proper IOL placement through rotation and visual inspection.
    c. A wound leak could cause anterior vaulting of the optic. Therefore a scleral tunnel or long multiplane limbal/ corneal incision is recommended with long narrow paracenteses. Ensure all incisions are watertight and do not leak.
    d. During surgery, the optic should be vaulted backward to a position corresponding to the normal location of the posterior capsule. Attempts to position the lens further posteriorly by hyper-inflating the  globe with BSS could lead to posterior vaulting and hyperopic outcomes, and should be avoided.
    e. Asymmetric and excessive fibrosis of the capsule may be associated with asymmetric vaulting. Contributing factors may include decentration or tear of the anterior or posterior capsule, or ruptured zonules. If any of these are present before lens implantation, do not implant the Crystallin’s.

MEDICAL DEVICE RE-USE STATEMENT

If this product is reprocessed and/or re-used, Bausch + Lomb cannot guarantee the functionality, material structure, or cleanliness or sterility of the product. Re-use could lead to illness, infection and/or injury to the patient or user and, in extreme incidents, death. This product is labeled as ‘single use’ which is defined as a device intended to be used once only for a single patient.

PRECAUTIONS

1. Do not reserialize this intraocular lens by any method (see RETURNED LENS POLICY).
2. Do not store lenses at temperatures over 45°C (113°F).
3. In cases where patients are monocular or have much poorer acuity in the fellow eye, they should exercise extreme caution if this happens in potentially hazardous situations (such as driving). If the patient experiences blurred vision, they should contact their physician promptly, as this may indicate a problem with lens positioning

ADVERSE EVENTS

The incidence of adverse events experienced during the clinical trial was comparable to or lower than the incidence reported in the historic control (“FDA grid”) population (see TABLE 10). As with any surgical procedure, risk is involved.
Potential adverse events accompanying cataract or implant surgery may include, but are not limited to, the following:
lens subluxation, corneal endothelial damage, non-pigment precipitates, cystoid macular edema, infection, retinal detachment, vitreous loss, pupillary block, secondary glaucoma, iris prolapse, vitreous-wick syndrome, uveitis, and pupillary membrane.

Vaulting
Vaulting is a post-operative adverse event where the Crystalens® lens optic hinges move into and remain in a displaced configuration. Vaulting events occurred at a rate of 0.3% (1 event / 324 subjects) in the clinical study conducted for the original Crystalens IOL (Model AT-45), and at a rate of 0.9% (2 events / 227 subjects; both arms combined) in the clinical study conducted for the Trulign Toric IOL (a modification having the same hinged haptic design; Model AT50T). The optic may be displaced anteriorly, posteriorly, or tilted/decentered. Vaulting takes three forms:

1. Anterior vault – both hinges are displaced anteriorly
2. Posterior vault – both hinges are displaced posteriorly
3. Asymmetric vault (z-syndrome) – one hinge is displaced anteriorly and one hinge is displaced posteriorly

Vaulting Symptoms:

• Vaulting typically presents with blurry vision, which may be either gradual or acute in onset.
• Blurry vision after cataract surgery may be due to various other conditions and patients are advised to contact their surgeons if they notice a change in vision.

Vaulting Diagnosis:

Diagnosis of vault is based on the IOL configuration, which can be visualized with a slit lamp. See footnotes 1, 2, 3, 4

• Anterior vault – both hinges and optic are displaced anteriorly, away from the posterior capsule.

• Posterior vault – both hinges and optic are displaced posteriorly, causing excessive posterior bowing of the posterior capsule.

• Asymmetric vault – one hinge displaced anteriorly and one posteriorly, causing the optic to tilt.
  Additional clinical findings that support the diagnosis of vault include: See footnotes 1, 2, 3, 4

• Excessive capsular contraction – fibrotic bands, striae, and opacification visualized at slit lamp

• Changes in refractive error – measured through manual or automatic refraction.

• Anterior vault – optic is displaced anteriorly, resulting in myopic shift.

• Posterior vault – optic is displaced posteriorly, resulting in hyperopic shift.

• Asymmetric vault – optic is tilted, resulting in astigmatism along the axis of tilt. Slit lamp photographic images of an asymmetric vault are included in footnotes 2, 3, and 4. Definitive causes of vaulting have not been established. Factors that have been suggested as potentially contributing to vaulting include the following:

• Asymmetric anterior capsulotomy – The Crystalens IOL is symmetric and the lens optic is intended to rest in the center of the capsular bag post-implantation. Asymmetric capsulotomy may result in asymmetric amount of capsular contact with the IOL which, during post-operative capsular contraction, may lead to asymmetric forces acting upon the IOL hinges. See footnotes 1, 2, 4

• Incomplete removal of lens material – Extensive medical literature has established that residual lens material can incite an exuberant post-operative inflammatory reaction. Post-operative inflammation can precipitate excessive capsular fibrosis, which may lead to excessive capsular contractile forces acting upon the IOL hinges. See footnotes 1, 2, 3, 4

• Capsular defect – A defect in the capsule will result in asymmetric capsular support for the IOL and possibly decentration or tilt of the IOL. During post-operative capsular fibrosis, these factors may lead to asymmetric contractile forces acting upon the IOL hinges and worsening of decentration / tilt. See footnote 4

• Zonular defect – Zonules provide support and balance for the capsular bag / IOL. Loss of zonular support can lead to decentration or tilt of the capsular bag and asymmetric forces acting upon the IOL hinges. See footnote 4

• Incorrect IOL placement – Examples of incorrect placement include: 1) IOL haptic footplates not evenly placed around the capsular equator; 2) one or more haptic footplates placed in the sulcus instead of the capsular bag; 3) IOL placed in an upside-down configuration. Each of these scenarios may cause the IOL to move in an asymmetric manner or the hinges to remain “stuck” in a flexed configuration. See footnote 4

• Wound leak – Wound leak allows fluid to egress from the anterior chamber to the external corneal surface, resulting in low and fluctuating levels of anterior chamber stability. Low anterior chamber  pressure relative to posterior vitreous pressure may push the IOL optic anteriorly, resulting in anterior vault. See footnotes 1, 4

• Excessive postoperative inflammation and excessive capsular fibrosis – Persistent post operative inflammation is associated with excessive capsular fibrosis. Capsular fibrosis may cause contractile forces to act upon the IOL hinges. See footnotes 1, 2, 3, 4

If any of the vaulting risk factors identified above are present before lens implantation, do not implant the Crystalens. See the “Warnings” section of this document. Warning 14 specifically pertains to vaulting problems.

Potential Sequelae of Vaulting:

• Vaulting commonly induces refractive error (e.g. myopia, hyperopia or astigmatism) which may be reversible if the Crystalens can be restored to its normal position.
• Vaulting commonly presents as blurry vision, which can be either gradual or acute in onset. Vaulting may be reversible by restoring the IOL to its normal position, which may require surgery.
• The treatment for vaulting may require secondary surgical intervention.

Physicians should consider the characteristics of each individual vaulting case prior to determining the appropriate treatment. Data on long-term follow- up after treatment of vaulting is not available.

CLINICAL TRIAL

The US clinical trial of the Crystalens® Model AT-45 was conducted in 497 eyes of 324 patients. The range of axial lengths studied in the clinical trial of Crystalens® was 21.0 to 26.6 mm and the dioptric power range was 16.5 to 27.5 D. The clinical results were obtained using an ‘A’ Constant of 119.0, the SRK/T formula, immersion biometry or interferometry and manual keratometry

RESULTS

The results achieved by 304 patients followed for one year provide the data that were used to support the conclusion that postoperatively, the majority of patients implanted with this lens achieve excellent near, intermediate, and distance vision without spectacles. Visual acuity with or without correction at all distances improves when both eyes are implanted with a Crystalens.®

1. In 124 bilaterally-implanted patients, the proportion of patients achieving uncorrected visual acuities of 20/32 (J2) or better at one year was:

Distance

| 97.6%
Intermediate|

100% at 80 cm

Near

|

93.5% at 40 cm

2. In the 74 bilaterally-implanted patients who were within ±0.5 D of plano in each eye, the proportion of patients achieving uncorrected visual acuities of 20/32 (J2) or better at one year was:

Distance

| 100%
Intermediate|

100% at 80 cm

Near

|

97.3% at 40 cm

The visual acuity and patient survey results are presented in TABLES 2-10.
The stability of the outcomes was demonstrated in a consistent cohort of patients across the Form 3 to Form 4 (1-2 months
to 3-6 months) and Form 4 to Form 5 (3-6 months to 11-15 months) postoperative intervals. Stability was measured using both the manifest spherical equivalent (MRSE) and visual acuity.
In a substudy comparing Crystalens® with a control population comprised of several models of standard IOLs of varying types (e.g., single piece, multipiece) and materials (e.g., silicone, acrylic), the visual acuity at all distances at 3-6 months postoperative was significantly greater in Crystalens® implanted eyes than in eyes implanted with a standard IOL. The results are shown in TABLE 1.
A clinical trial of the model AT-45-HD100 consisting of 123 subjects followed for 4-6 months was conducted. In TABLE 11, the visual acuity results are compared to the parent Model AT-45.

DETAILED DEVICE DESCRIPTION

Lens Optic

• Material: Silicone Elastomer (Biosil)

• Light transmittance: 95% (±5%) in the visible region of the light spectrum (425-750 nm). UV cut-offs at 10% T for a
  20.0 diopter equivalent occurs at 400 nm +/- 7 nm as shown in FIG. 3

• Index of refraction: 1.430 (35˚C)

Lens Models

Crystalens® AO Model AO1UV (see FIG. 1)

Overall diameter: 11.5 mm
Diopter power: +17 to +33 (0.5 increments) +17 to +27 (0.25 increments)

Crystalens® AO Model AO2UV (see FIG. 2)

Overall diameter: 12.0 mm
Diopter power: +4 to +9 (1.0 increments) +10 to +16 (0.5 increments) +16.0 to +27 (0.25 increments) +27.5 to +33 (0.5 increments)

CRYSTALENS® AO IOL – ASPHERIC INFORMATION

Crystalens® AO has prolate aspheric surfaces and is designed to be free of spherical aberration. The image quality of
Crystalens® AO is illustrated in FIG. 4 in the form of a modulation transfer function curve.
NOTE: Based on bench testing, the lens models with aspheric surfaces may provide somewhat reduced near acuity compared to the spherical model. No clinical study was performed to verify these findings or to assess the effect of the added aspheric surface on spherical aberration, night-time distance visual acuity, and contrast sensitivity compared to the parent model Crystalens® model AT-45.
NOTE: The image quality of model AO1UV was characterized by measuring modulation transfer function (MTF) in a model eye described in ISO 11979-2 through 3-mm and 4.5-mm lens apertures.

HAPTICS

The plate haptics have hinges across the face of the plates adjacent to the optic. Two flexible colored polyimide (Kapton) loops are attached to each distal extremity of the plates (see lens illustrations for overall length per model). The length of the plate is 10.5 mm.

MECHANISM OF ACTION

Crystalens® was designed to move in a backward and forward motion along the axis of the eye in response to pressure changes in the vitreous cavity and anterior chamber that result from relaxation and contraction of the ciliary muscle. The exact mechanism of action has not been fully elucidated.

DIRECTIONS FOR USE

1. Prior to implanting, examine the lens package for IOL type, power, and expiration date.

2. Open the peel pouch and remove the lens from the sterile packaging by pressing and lifting the cover off the plastic
   lens case (holder). Place the lens in a sterile environment.

3. Examine the lens thoroughly to ensure particles have not become attached to it, and examine the lens optical surface
   for other defects.

4. Position the lower blade of the forceps in the slot of the lens case beneath the lens. A Cumming intraocular lens
   forceps is recommended. Grasp the lens so that the forceps extends across the distal hinge to stabilize the leading
   plate haptic. Do not grasp the lens by the haptics.

5. Remove the lens in its position for implantation with a single grasp.

6. Advance the forceps to place the leading plate haptic of the lens into the distal capsular bag, which should be
   completely filled with a cohesive viscoelastic.

7. The round knob on the loop of the leading haptic should be on the right to ensure that the hinge’s “open” side is “right
   side up” and is facing the anterior part of the eye on implantation.

8. With a second instrument, hold the proximal polyimide loop to maintain the position of the lens in the capsular bag
   as the implantation forceps are withdrawn from the eye.

9. Regrasp at the tip of the trailing plate haptic with the implantation forceps.

10. As you advance the trailing plate haptic into the anterior chamber, the polyimide loops will bend back on themselves
    as they traverse the small incision. Advance the leading plate up towards the cornea. This will cause the leading plate
    haptic to bend to a right angle deep into the bag.

11. Maintain your grasp at the tip of the trailing plate haptic. Tuck the polyimide loops, one by one, into the capsular bag.
    Do not release the tip until the loops are in the bag.

12. Release and withdraw the forceps. The lens will self-center.

NOTE: The lens may pick up an electrostatic charge upon opening the package. The lens should be carefully examined to ensure that particles have not been attracted to its surface.

INSERTION DEVICE DETAILS

The Crystalsert® delivery system is recommended to be used to inject Crystalens®. A cohesive viscoelastic should be used for lubrication of the injector when inserting the IOL. The IOL should be injected within three minutes after loading. Refer to the instructions for use supplied with the injector. See http://www.Crystalens.com for further details on the use of the injector with Crystalens®.

LENS POWER CALCULATIONS

The surgeon should determine preoperatively the power of the lens to be implanted by using either immersion or IOL Master biometry and manual keratometry. Lens power calculation methods are described in the following references:

• Holladay JT et al. A Three Part System for Refining Intraocular Lens Power Calculations.
  J Cataract Surg 14, January 1988.

• Ratleff JA et al. Development of the SRK/T intraocular lens implant power calculation formula.
  J Cataract Refract Surg 16, May 1990.

• Hoffer KJ. The Hoffer Q Formula. A comparison of theoretical and regression formulas.
  J Cataract Refract Surg 19, November 1993.
  NOTE: The Surgeon Factor, ‘A’ Constant and ACD values, which are located on the outside of the package, are estimates only. It is recommended that the surgeon determine his/her own values based on their individual clinical experience. Surgeons requiring additional information on lens power calculation may contact Bausch + Lomb.

RECOMMENDATIONS FOR MAXIMIZING PATIENT OUTCOMES

• IOL Master or manual keratometry, immersion biometry or interferometry is strongly recommended to obtain optimum patient outcomes.
• The first eye implant should be targeted for between -0.25 and -0.50 diopter and the second eye implant targeted for Plano. In any case, the outcome of the second eye implant should be determined based on the outcome of the first eye.
• A waiting period of two weeks between the first and second eye is recommended in order to accurately determine the lens power for the second eye.
• Incision width should be 3.5 to 3.7 mm but no larger than 4 mm and should be at least 2.5 mm long. The paracentesis should be approximately 1.0 to 1.5 mm in width and approximately 2.0 mm long.
• The capsulorhexis should be round (5.5 to 6.0 mm) with the anterior capsule covering the plate haptics. If the capsulorhexis is oval, then the lens should be rotated to ensure maximum coverage of the plate haptics.
• Meticulous cortical clean-up should be performed and the lens rotated at least 90˚ to dislodge any hidden or trapped cortex.
• Patients should be kept on a tapering course of anti-inflammatory agents for a minimum of 4 weeks after surgery.
  The surgeon may want to consider a longer course of anti-inflammatory therapy for patients with signs of residual inflammation or capsular striae. See footnotes 1, 4

PATIENT REGISTRATION INSTRUCTIONS AND REPORTING REGISTRATION

Each patient who receives Crystalens® must be registered with Bausch + Lomb at the time of lens implantation. Registration is accomplished by completing the Implant Registration Card that is enclosed in the lens package and mailing it to Bausch + Lomb. Patient registration is essential and will assist Bausch + Lomb in responding to adverse reaction reports and/or potentially sight- threatening complications. An implant identification card is supplied in the lens package and must be given to the patient.

REPORTING

Adverse reactions and/or complications should be reported to Bausch + Lomb at 866-393-6642 (USA).

HOW SUPPLIED

The contents of the inner and outer peel pouches are sterile unless the packages are damaged or opened. The intraocular lenses are moist heat sterilized and supplied in a lens case within a double aseptic transfer peel pouch.

EXPIRATION DATE

Sterility is guaranteed unless the sterile pouch is damaged or opened. In addition, there is a sterility expiration date that is clearly indicated on the outside of the package. The lens should not be used after the indicated date.

RETURNED LENS POLICY

Please contact your local Bausch + Lomb office regarding lens exchange.

FOOTNOTES

1. Page, Timothy and Whitman, Jeffrey. “A stepwise approach to the management of capsular contraction syndrome in hinged-based accommodative intraocular lenses.” Accepted for publication by Journal of Clinical Ophthalmology.
2. Yuen, Leonard; Trattler, William and Boxer-Wachler, Brian. “Two cases of Z syndrome with the Crystalens after uneventful cataract surgery.” Journal of Cataract & Refractive Surgery 34.11 (2008): 1986-1989.
3. Jardim, Daniela; Soloway, Barrie and Starr, Christopher. “Asymmetric vault of an accommodating intraocular lens.” Journal of Cataract & Refractive Surgery 32.2 (2006): 347-350.
4. Musket, Samuel. “Cataract Surgical Problem: Consultation” Journal of Cataract & Refractive Surgery 36.2 (2010): 354 358.

BIBLIOGRAPHY

1. Buettner, EA and Wolters JR 1962. Transmission of the ocular media. Invest Ophthalmic 1: 776-783.

2. Bicocca, A. La Physiologies Du Muscle Cilia ire Etude Par La Gonioscopes. Annales D’Oculistique 1955; 1–21.

3. Coleman J. On the hydraulic suspension theory of accommodation. Trans Am opt Sac 1986; 846-868.

4. Colin, J. Clinical results of implanting a silicone haptic-anchor-plate intraocular lens. J Cataract Refract Surg,
   1996;2:1286–1290.

5. Cumming JS et al. Clinical evaluation of the Model AT-45 silicone accommodating intraocular lens. Ophthalmology
   2001;108:2005-2010.

6. Cumming JS, Ritter J. The Measurement of Vitreous Cavity Length and its Comparison Pre- and Postoperatively. Eur J Implant Ref Surg 1994;6:261–272.

7. Fisher R. The ciliary body in accommodation. Tran Ophthalmic Soc UK 1986;105:208-219.

8. Girard LJ et al. Complications of the Simcoe Flexible Loop Phacoprosthesis in the anterior chamber. Ophthalmic Surg 14(4).

9. Glasser A and Kaufman PL. The mechanism of accommodation in primates. Ophthalmic 1999;106: 863-872.

10. Kaman J. Vitreous-stabilizing, single-piece, mini-loop, plate-haptic silicone intraocular lens. J Cataract Refract
    Surg 1998;24:98–106.

11. Thornton S. Accommodation in pseudo phakia. Color Atlas of Lens Implantation. 1991;159–162.

12. Willis DA, Stewart RH, Kimbrough RL. Pupillary block associated with posterior chamber lenses. Ophthalmic Surg
    1985; 16:108-9.

TABLE 1

CRYSTALENS® VS STANDARD IOL VISUAL ACUITY (BEST SPECTACLE CORRECTED DISTANCE AND NEAR AND INTERMEDIATE ACUITY THROUGH THE DISTANCE CORRECTION)

| CRYSTALENS®| STANDARD IOL
---|---|---
20/20 or better| 1/121| 0.8%| 0/64|

0%

20/25 or better

| 29/121| 24.0%| 0/64| 0%
20/32 or better| 61/121| 50.4%| 3/64|

4.7%

20/40 or better

| 107/121| 88.4%| 23/64| 35.9%
Worse than 20/40| 14/121| 11.6%| 41/64|

64.1%

TABLE 2
BILATERAL – UNCORRECTED VISUAL ACUITY

| NEAR AT 40 CM| INTERMEDIATE AT 80 CM| DISTANCE
---|---|---|---
20/20 or better| 39/124| 31.5%| 120/124| 96.8%| 98/123|

79.7%

20/25 or better

| 90/124| 72.6%| 122/124| 98.4%| 113/123| 91.9%
20/32 or better| 116/124| 93.5%| 124/124| 100%| 120/123|

97.6%

20/40 or better

| 122/124| 98.4%| 124/124| 100%| 121/123| 98.4%
Worse than 20/40| 2/124| 1.6%| 0/124| 0%| 2/123|

1.6%

TABLE 3
BILATERAL – UNCORRECTED VISUAL ACUITY FOR PATIENTS WITHIN ±0.5D OF PLANO IN EACH EYE

| NEAR AT 40 CM| INTERMEDIATE AT 80 CM| DISTANCE
---|---|---|---
20/20 or better| 17/74| 23.0%| NA| NA| 67/74|

90.5%

20/25 or better

| 49/74| 66.2%| 74/74| 100%| 73/74| 98.6%
20/32 or better| 72/74| 97.3%| 74/74| 100%| 74/74|

100%

20/40 or better

| 74/74| 100%| 74/74| 100%| 74/74| 100%
Worse than 20/40| 0/74| 0%| 0/74| 0%| 0/74|

0%

TABLE 4
BILATERAL UNCORRECTED VISUAL ACUITY (1 YEAR VERSUS 3 YEAR)

|

NEAR AT 40 CM

| DISTANCE
---|---|---
1 Year| 3 Year| 1 Year|

3 Year

20/25 or better

| 90/124| 72.6%| 36/50| 72.0%| 113/123| 91.9%| 46/50| 92.0%
20/32 or better| 116/124| 93.5%| 43/50| 86.0%| 120/123| 97.6%| 47/50|

94.0%

20/40 or better

| 122/124| 98.4%| 49/50| 98.0%| 121/123| 98.4%| 49/50| 98.0%
Worse than 20/40| 2/124| 1.6%| 1/50| 2.0%| 2/123| 1.6%| 1/50|

2.0%

TABLE 5
BILATERAL DISTANCE CORRECTED NEAR VISUAL ACUITY (1 YEAR VERSUS 3 YEAR)

| 1 YEAR|

3 YEAR

---|---|---

20/25 or better

| 64/124| 51.6%| 29/50|

58.0%

20/32 or better

| 104/124| 83.9%| 42/50| 84.0%
20/40 or better| 124/124| 100%| 50/50|

100%

Worse than 20/40

| 0/124| 0%| 0/50|

0%

TABLE 6
UNILATERAL – UNCORRECTED VISUAL ACUITY (ALL EYES)

| NEAR AT 40 CM| INTERMEDIATE AT 80 CM| DISTANCE
---|---|---|---
20/20 or better| 52/368| 14.1%| —| —| 184/371|

49.6%

20/25 or better

| 161/368| 43.8%| —| —| 269/371| 72.5%
20/32 or better| 256/368| 69.6%| —| —| 311/371|

83.8%

20/40 or better

| 328/368| 89.1%| —| —| 339/371| 91.4%
Worse than 20/40| 40/368| 10.9%| —| —| 32/371|

8.6%

TABLE 7
BILATERAL PATIENT SURVEY*
ACTIVITIES WITHOUT SPECTACLES, US BILATERAL SUBJECTS

ACTIVITY

| YES

N/N (%)

|

NO

N/N (%)

---|---|---

Perform most visual functions

| 120/128 (93.8%)| 8/128 (6.3%)
Read most things| 100/129 (77.5%)|

29/129 (22.5%)

Go shopping

| 116/124 (93.5%)| 8/124 (6.5%)
Participate in sports| 84/87 (96.6%)|

3/87 (3.4%)

Attend social gatherings

| 120/126 (95.2%)| 6/126 (4.8%)
Drive| 111/121 (91.7%)|

10/121 (8.3%)

Read a newspaper

| 73/128 (57.0%)| 55/128 (43.0%)
Sew or do needlework| 35/91 (38.5%)|

56/91 (61.5%)

Work on a computer

| 75/93 (80.6%)| 18/93 (19.4%)
Do handy work around the house| 119/126 (94.4%)|

7/126 (5.6%)

Walk

| 126/129 (97.7%)| 3/129 (2.3%)
Shop| 117/128 (91.4%)|

11/128 (8.6%)

Watch television

| 120/130 (92.3%)|

10/130 (7.7%)

TABLE 8
BILATERAL PATIENT SURVEY DIFFICULTY WITH NIGHT ACTIVITY, US BILATERAL SUBJECTS

SYMPTOMS

| ABSENT

N/N (%)

| MILD

N/N (%)

| MODERATE

N/N (%)

| SEVERE

N/N (%)

---|---|---|---|---

Night-time glare/flare

| 74/130 (56.9%)| 31/130 (23.8%)| 18/130 (13.8%)|

7/130 (5.4%)

Night vision

(difficulty driving at night)

| 82/121 (67.8%)| 21/121 (17.4%)| 14/121 (11.6%)|

4/121 (3.3%)

Halos (rings around lights)

| 80/130 (61.5%)| 26/130 (20.0%)| 16/130 (12.3%)|

8/130 (6.2%)

TABLE 9
BILATERAL PATIENT SURVEY
WEARING SPECTACLES DURING WAKING HOURS AND TO SEE AT NIGHT , US BILATERAL SUBJECTS

WEARING SPECTACLES

| N/N (%)
---|---

HOW OFTEN DO YOU WEAR SPECTACLES DURING WAKING HOURS?

I do not wear spectacles

| 33/128 (25.8%)
I wear spectacles almost none of the time (10%-25%)|

61/128 (47.7%)

I wear spectacles some of the time (26%-50%)

| 20/128 (15.6%)
I wear spectacles most of the time (51%-75%)|

8/128 (6.3%)

I wear spectacles all the time or almost all the time (76%-100%)

|

6/128 (4.7%)

DO YOU WEAR SPECTACLES TO SEE AT NIGHT?

No

| 110/130 (84.6%)
Yes|

20/130 (15.4%)

TABLE 10
ADVERSE EVENTS REPORTED AT 12 MONTHS

ADVERSE EVENT

| CUMULATIVE| FDA GRID| PERSISTENT| FDA GRID
---|---|---|---|---
PRIMARY EYES| ALL EYES| PRIMARY EYES|

ALL EYES

Endophthalmitis

| 1/324 (0.3%)| 1/497 (0.2%)| 0.1%| —-| —-| —-
Hyphema| 1/324 (0.3%)| 1/497 (0.2%)| 2.2%| —-| —-|

—-

Hypopyon

| 0/324| 0/497| 0.3%| —-| —-| —-
IOL Dislocation| 0/324| 0/497| 0.1%| —-| —-|

—-

Cystoid Macular Edema

| 12/324 (3.7%)| 13/497 (2.6%)| 3.0%| 2/304 (0.7%)| 3/450 (0.7%)| 0.5%
Pupillary Block| 0/324| 0/497| 0.1%| —-| —-|

—-

Retinal Detachment

| 0/324| 0/497| 0.3%| —-| —-| —-
Secondary Surgical Reintervention| 2/324 (0.6%)| 4/497 (0.8%)| 0.8%| —-| —-|

—-

Corneal Edema

| —-| —-| —-| 0/298| 0/440| 0.3%
Iritis| —-| —-| —-| 2/298 (0.7%)| 3/440 (0.7%)|

0.3%

Raised IOP Requiring Treatment

| —-| —-| —-| 0/304| 0/450|

0.4%

TABLE 11
AT-45-HD100 SUMMARY OF EFFECTIVENESS AT 4–6 MONTH FOLLOW-UP PRIMARY EYES (WITHIN 0.50D OF TARGET REFRACTION)

| HD100| MODEL AT-45
---|---|---

EFFECTIVENESS

| 20/40 or better|

20/40 or better

VISUAL ACUITY (VA)| N = 67|

N = 149

NEAR

Uncorrected (UNVA)

| 89.6%| 89.3%

INTERMEDIATE

Uncorrected (UIVA)| 100%|

Not recorded

DISTANCE

Uncorrected (UDVA)| 95.5%|

87.9%

SYMBOL

Manufacturer

Do not reuse

Use By, YYYY-MM-DD

Date of manufacture (YYYY-MM-DD)

Consult instructions for use

Sterilized using steam

Upper limit of temperature

Authorised representative in the European community

Member Green Dot Scheme

Do not reserialize

Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a licensed practitioner

Do not use if the package is damaged

Customer Support

Bausch & Lomb Incorporated
1400 North Goodman Street
Rochester, NY 14609 USA

Bausch & Lomb GmbH
Brunsbütteler Dam 165-173
13581 Berlin, Germany
Manufacturing Site:
Bausch & Lomb Incorporated
21 Park Place Blvd. North, Clearwater, FL 33759 USA ®/
™ are trademarks of Bausch & Lomb Incorporated or its affiliates.
©Bausch & Lomb Incorporated
4125004
Rev. 2018-09

References

• Bausch + Lomb Products for Eye Care and Contact Lenses
• Bausch + Lomb Products for Eye Care and Contact Lenses

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