Salient Characteristics_Phakic Intraocular Lens Implants.docx

SALIENT CHARACTERISTICS

PHAKIC INTRAOCULAR LENS IMPLANTS FOR SURGERY

1. Must be made of a collamer material which will allow for implantation and explantation which causes minimal intrusion into the anterior segment of the eye

2. Must be a single piece lens

3. Must be able to be injected through an injection cartridge which can be inserted into a hole (a hole in the eye which is created with a micro-scalpel blade) that is between 3.0 mm and 3.2 mm wide

4. Must be designed to be implanted behind the pupil in a phakic eye (a phakic eye has the presence of the natural anatomical lens). Must be implanted in such a way as to not touch the natural anatomical lens of the eye.

5. Must come in overall diameter sizes of 12.1, 12.6, 13.2 and 13.7 mm (+ or – 0.1 mm for each size)

6. Must be available in Dioptric powers between -3.0 and -15.0 in half diopter steps

7. Must be available in Dioptric Cylindrical powers between -1.5 and -4.0 in half diopter steps

8. Must have an optic diameter of no less than 4.9 mm and no more than 5.8 mm (plus or minus 0.1 mm)

9. The optic must be aspheric or a convex/concave diverging optic.