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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.
 
DeviceAKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
Bausch & Lomb, Inc.
50 technology drive
irvine, CA 92618
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S019 S020 
S021 S022 S023 
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