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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameAKREOS POSTERIOR CHAMBER INTRAOCULAR LENS, AO60, M160
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP060022
Supplement NumberS014
Date Received09/07/2012
Decision Date10/04/2012
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
New supplier for the 2-hydroxyl ethyl methacrylate (hema) monomer used in the manufacture of akreos iols.
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