This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the allergan, inc. Model ac21b ultraviolet-absorbing pmma anterior chamber intraocular lens, available in three overall diameters (12. 0 mm, 13. 0 mm, 14. 0 mm). The application is a licensing pma in which allergan, inc. Has giving ophthalmic innovations international, inc. Reference rights to p860034. Additionally, it is requested that allergan, inc. Distribute the lens as the duralens ii model ac21b. The device is indicated for the replacement of the human lens in the visual correction of aphakia. The anterior chamber intraocular lens is to be used in patients 60 years of age and older where a cataractous lens has been removed by primary intracapsular cataract extraction (icce); or by primary extracapsular cataract extraction (ecce) where there is a structural reason that the anterior chamber lens is the preferred one; or other primary ecce provided that this be performed only after the physician has compared the published results of the anterior chamber lens with posterior chamber lenses; or in a secondary implant procedure.
| Device | ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT) |
| Generic Name | Intraocular Lens |
| Applicant | AAREN SCIENTIFIC |
| Date Received | 2001-04-30 |
| Decision Date | 2001-11-21 |
| Notice Date | 2002-05-07 |
| PMA | P010027 |
| Supplement | S |
| Product Code | HQL |
| Docket Number | 02M-0180 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AAREN SCIENTIFIC 4290 East Brickell St, Bldg A ontario, CA 91761 |
| Summary: | Summary of Safety and Effectiveness |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P010027 | Original Filing | |
| S005 | 2012-02-02 | 30-day Notice |
| S004 | 2012-02-02 | 30-day Notice |
| S003 | 2009-10-28 | 135 Review Track For 30-day Notice |
| S002 | 2008-08-13 | 30-day Notice |
| S001 | 2008-08-13 | 30-day Notice |