Akreos MI60 Adapt Acrylic Lens Instruction Manual

Akreos MI60 Adapt Acrylic Lens

Product Information

• Specifications:
  • Product Name: Intraocular Lenses
  • Models: Adapt Acrylic Lens (Adapt), Advanced Optics Aspheric Lens (Adapt AO), Micro Incision Lens (MI60)
  • Lens Powers Available: From +0 to +30 diopters (D) by steps of 0.5D or 1D depending on the model
  • Manufacturer: Bausch & Lomb Incorporated

Product Usage Instructions

• Opening Instructions:
  • Open the carton and remove the sterilized pouch containing the lens vial.
  • Gradually peel the pouch apart to release the lens vial onto the sterile field.
  • Before opening the lens vial, make a final check of the IOL and its power.
• Removing Lens from Vial:
  • Hold the vial with the pull tab of the foil lid pointing towards you.
  • Peel the foil lid away to expose the holder inside the vial.
  • Lift the holder out of the vial and remove the protective cover.
  • Grasp the optic along the 6-12 o’clock axis with forceps and pull upwards to remove the lens from the holder.
  • Rinse the lens with a sterile balanced salt solution.
• Lens Orientation:
  • Adapt: ​​No specific orientation is required.
  • Adapt AO and MI60: The lens should be implanted with the anterior side facing the anterior side of the eye. Verify orientation by inspecting haptics.

Validated Inserter:

FAQ:

• Q: What lens powers are available for Akreos IOLs?
  • A: Akreos IOLs are available from +0 to +30 diopters (D) by steps of 0.5D or 1D depending on the model and the diopter range.

INTRAOCULAR LENSES

DESCRIPTION:

• The Akreos flexible IOL is a single-piece lens cut from a hydrophilic acrylic copolymer that contains a UV absorber.
• The overall length varies according to IOL power.
• The composition and characteristics of the Akreos IOL are specified on the carton label.

INDICATIONS:

• The Akreos posterior chamber lens is indicated for primary implantation for the visual correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular extraction methods.
• The lens is designed for implantation in the capsular bag following extracapsular cataract extraction.

CONTRA-INDICATIONS

• Implantation is not advisable when the IOL may aggravate an existing condition, interfere with the diagnosis or the treatment of a pathology, or present a risk to the sight of the patient.
• These conditions are uncontrolled glaucoma, rubeotic cataract, retinal detachment, atrophy of the iris, microphthalmia, developing chronic eye infections, endothelial corneal dystrophy, peri-operative complications (such as vitreous loss, hemorrhage…), foreseeable post-operative complications.

WARNING:

• As with all surgical procedures, cataract surgery with IOL implantation presents risks that the surgeon must evaluate.

Potential complications of cataract surgery are:

• Inflammation (iridocyclitis, pupillary membrane, vitreous inflammation, CME …), infection (endophthalmitis…), retinal detachment, pupillary block, iris hernia, flattening of the anterior chamber, hemorrhage (hyphema), corneal dystrophy, glaucoma, atrophy of the iris.

Amongst those directly linked to the IOL are:

• Decentering and subluxation precipitate on the surface of the IOL.
• Silicone oil, particularly when used in the surgical treatment of detached retina, may stick to IOLs if the posterior capsule is not intact.

PACKAGING / STERILIZATION:

• The Akreos IOL is individually packaged in a pouch and vial containing 0.9% saline solution that should be opened under sterile conditions.
• The IOL is located in a lens holder within the vial.
• A patient card and self-adhesive labels are supplied to provide traceability of the IOL.
• These are supplied in the carton containing instructions for use (diagram and characteristics of the IOL, serial number, expiration date…).
• The Akreos IOL is steam sterilized.

PRECAUTIONS FOR USE AND STORAGE

• Store at room temperature. Avoid high temperatures (> 45˚C). Do not use the IOL if the carton box or its seal integrity has been opened or damaged.
• The IOL should be used in the shortest possible time after opening the vial.
• The IOL model, its power and expiration date should be verified before opening the protective packaging and before opening the individual sterile pouch.
• Sterility of the IOL is guaranteed only if the individual sterile pouch has not been opened or damaged.
• Akreos IOLs can absorb substances that they contact (disinfectants, drugs…). Consequently, Akreos lenses must be carefully rinsed with sterile balanced salt solution.
• If a YAG laser posterior capsulotomy is performed, ensure that the laser beam is focused slightly behind the posterior capsule.
• Do not attempt to sterilise these lenses as this can produce undesirable side effects.
• Do not re-use the IOL. It is intended for permanent implantation. If explanted, sterility and proper function cannot be assured.

OPENING INSTRUCTIONS

• Open the carton and remove the sterilized pouch containing the lens vial.
• Gradually peel the pouch apart to release the lens vial onto the sterile field.
• Before opening the lens vial, make a final check of the IOL and its power.

(Please refer to the enclosed figures):

• FIG. 1: Hold the vial in one hand, with the pull tab of the foil lid pointing towards you. Your thumb should be pressed against the flattened side of the vial’s profile. Grasp the pull tab of the foil lid and peel the foil lid away from you to expose the holder inside the vial.
• FIG. 2: Carefully lift the holder out of the vial.
• FIG. 3: Position the holder so that the circular hole on top of the protective cover is facing up. Remove the protective cover by grasping the exposed tab, bending it upward, away from the holder and pulling it off

Remove the lens from the holder by gently grasping the optic along the 6-12 o’clock axis with forceps and pulling upwards. The IOL will be anterior side up in the forceps. Examine the lens closely and rinse with sterile balanced salt solution. Only insertion instruments and viscoelastics that have been validated and approved for use with this lens should be used.

Note: please refer to the directions for use with the insertion instrument for additional information.

LENS ORIENTATION:

• Adapt – there is no orientation required.
• Adapt AO and MI60 – the lens is to be implanted with the anterior side of the lens facing the anterior side of the eye.

The orientation of the IOL can be verified by visual inspection of the haptics. As illustrated in FIG. 4 and FIG. 5, when the haptic features are top right (A) and bottom left (B), the lens is positioned properly.

VALIDATED INSERTER:

PHYSICAL CHARACTERISTICS:

• The refractive index of the lens when wet at 20˚C = 1.459.
• The refractive index of the lens when in the eye is 35˚C = 1.458.

WARRANTY

• Bausch & Lomb Incorporated warrants that the intraocular lens, when delivered, will conform to all applicable laws and the manufacturer’s then-current version of the published specifications for such intraocular lens in all material respects and will be free from defects in material or workmanship.

BAUSCH & LOMB INCORPORATED DISCLAIMS ALL OTHER WARRANTIES, EXPRESS, IMPLIED OR BY OPERATION OF LAW, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. BAUSCH & LOMB INCORPORATED SHALL NOT BE LIABLE FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT OR EXEMPLARY DAMAGES OF ANY KIND, DIRECTLY OR INDIRECTLY ARISING FROM THE PURCHASE OR USE OF THIS PRODUCT EVEN IF BAUSCH & LOMB INCORPORATED HAD BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS, DAMAGE OR EXPENSE.

RETURN GOODS POLICY: All

• lenses being returned must be accompanied by an authorization number issued by Bausch & Lomb Customer Service.
• Opened or unopened lenses will be exchanged for a comparable monetary value, provided they have not exceeded their expiration date.
• A reprocessing charge may be assessed for lenses that have exceeded their expiration date.
• This applies to opened or unopened lenses.
• It is not Bausch & Lomb’s policy to issue credit or cash refunds for returned lenses.

UV TRANSMITTANCE CURVE

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