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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.
 
Trade NameAKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP060022
Date Received06/29/2006
Decision Date09/05/2008
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 08M-0515
Notice Date 09/19/2008
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the akreos posterior chamber intraocular lens (iol), model: akreos advanced optics aspheric lens, ao60. The device is indicated for primary implantation for the visual correction of aphakia in adult patients where a cataractous lens has been removed by phacoemulsifi-cation. The lens is intended to be placed in the capsular bag.
Approval Order Approval Order
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S019 
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