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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.
 
DeviceAcrySof® IQ Aspheric IOL with the UltraSertTM Pre-loaded Delivery System AU00T0
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy. Dr.
Fort Worth, TX 76134
PMA NumberP930014
Supplement NumberS092
Date Received07/20/2016
Decision Date10/12/2016
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 modifications to your real time shelf life protocol to substitute the aerosol microbial challenge test with the microbial barrier test and to add a seal strength test for your AcrySof® IQ Aspheric IOL with the UltraSertTM Pre-Loaded Delivery System, Model AU00T0.
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