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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/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.
Generic Nameintraocular lens
Regulation Number886.3600
4290 east brickell st, bldg a
ontario, CA 91761
PMA NumberP970034
Date Received07/21/1997
Decision Date09/25/1998
Withdrawal Date 08/20/2014
Product Code HQL 
Docket Number 98M-0855
Notice Date 10/27/1998
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Indicated for the visual correction of aphakia in persons 60 years of age or older, who are undergoing extracapsular cataract extraction and primary lens implantation. The intraocular lens is intended to permanently replace the natural cataractous crystalline lens and to restore useful vision. It is intended for capsular bag placement only. The devices are available in a range of powers from 4 diopters (D) to 34D in 0.5D increments.
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014