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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 ReStor Posterior Chamber Intraocular Lenses
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAlcon Research, Ltd.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP040020
Supplement NumberS079
Date Received05/02/2018
Decision Date07/31/2018
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 a second alternate sterilization chamber at the contract sterilization site for the AcrySof® and AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses.
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