RayOneAspheric
INDICATIONS: The Rayner 600C intraocular lens is indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by
phacoemulsification. The lens is intended to be placed in the capsular bag.
CONTRAINDICATIONS: Apart from non-specific contraindications related to any form of ocular surgery, the following specific contraindications must be respected.
1. Microphthalmia
2. Active ocular disease (e.g. chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)
3. Children under the age of 21 years
4. Corneal decompensation or corneal endothelial cell insufficiency
5. Persons who are pregnant or nursing
WARNINGS: A risk/benefit ratio must be assessed before confirming a patient as a candidate for the Rayner 600C IOL implantation, if they are suffering from any of the following conditions:
1. Recurrent ocular disease (e.g. uveitis, diabetic retinopathy, glaucoma, corneal decompensation)
2. Previous ocular surgery
3. Non-age-related cataract
4. Vitreous loss
5. Iris atrophy
6. Severe Aniseikonia
7. Ocular Hemorrhage
8. Macular degeneration
9. Zonular dehiscence
10. Ruptured posterior capsule
11. Patients in whom the intraocular lens may affect the ability to observe, diagnose, or treat posterior segment diseases.
12. Surgical difficulties at the time of cataract extraction which might increase the potential for complications (e.g. persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss)
13. A distorted eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible.
14. Circumstances that would result in damage to the endothelium during implantation.
15. Suspected microbial infection.
16. Children under the age of 2 years are not suitable candidates for intraocular lenses.
Since the Rayner 570C C-flex IOL clinical study was conducted with lens implantations into the capsular bag only, there is insufficient data to demonstrate the safety and efficacy for ciliary sulcus placement of the 570C or 600C IOLs.
ATTENTION: Reference the Instructions for Use labeling for complete listing of indications and precautions.
CAUTION: Federal U.S law restricts this device to the sale by, or on the order of a physician.
