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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
4290 east brickell st, bldg a
ontario, CA 91761
PMA NumberP010027
Date Received04/30/2001
Decision Date11/21/2001
Withdrawal Date 08/20/2014
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 02M-0180
Notice Date 05/07/2002
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
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
Summary Summary of Safety and Effectiveness
Supplements: S001 S002 S003 S004 S005