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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAKREOS POSTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Dr.
Irvine, CA 92618
PMA NumberP060022
Supplement NumberS002
Date Received10/24/2008
Decision Date02/18/2009
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE PACKAGING, LABELING AND DESIGN OF THE AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL: AKREOS ADVANCED OPTICS ASPHERIC INTRAOCULAR LENS, AO60. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AKREOS AO MICRO INCISION LENS, MODEL MI60L AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS IN THE VISUAL CORRECTION OF APHAKIA.
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