This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for changes to the warning section of the lens package insert. Specifically: "when implanting a lens with a smaller optic (less than or equal to 5. 5mm), it is recommended that capsulorhexis, with a diameter smaller than the lens optic, be performed. A thorough cortical cleaning before lens insertion is also recommended. "
| Device | CEEON MODEL 912 FOLDABLE INTRAOCULAR LENS |
| Generic Name | Intraocular Lens |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1999-07-01 |
| Decision Date | 1999-07-30 |
| PMA | P940007 |
| Supplement | S005 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ADVANCED MEDICAL OPTICS, INC. 1700 E. St. Andrew Place p.o. Box 25162 santa Ana, CA 92705-4933 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P940007 | Original Filing | |
| S006 | 2000-09-05 | Normal 180 Day Track |
| S005 | 1999-07-01 | Special (immediate Track) |
| S004 | 1998-07-31 | Normal 180 Day Track |
| S003 | ||
| S002 | 1996-10-17 | Normal 180 Day Track |
| S001 | 1995-10-30 | Normal 180 Day Track |