| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT) |
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| Classification Name | intraocular lens |
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| Regulation Number | 886.3600 |
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| Applicant | AAREN SCIENTIFIC |
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| PMA Number | P010027 |
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| Date Received | 04/30/2001 |
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| Decision Date | 11/21/2001 |
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| Product Code | |
| Docket Number | 02M-0180 |
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| Notice Date | 05/07/2002 |
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| Advisory Committee |
Ophthalmic |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
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. |
| Approval Order |
Approval Order
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| Supplements: |
S001 S002 S003 S004 S005 |
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