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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
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP060022
Supplement NumberS012
Date Received06/22/2011
Decision Date06/18/2012
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the primary packaging which includes an alternate plastic vial and intraocular lens (iol) holder.
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