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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.
 
DevicePMMA Multi-Piece Posterior Chamber Intraocular Lenses
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantALCON LABORATORIES
6201 S FREEWAY
FT WORTH, TX 76134
PMA NumberP810032
Supplement NumberS069
Date Received03/25/2019
Decision Date04/22/2019
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Use the membrane filtration recovery method for bioburden testing of the AcrySof® Intraocular Lenses.
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