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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.
 
DeviceVISCOAT™ Ophthalmic Viscosurgical Device; DUOVISC™ Ophthalmic Viscosurgical System; DISCOVISC™ Ophthalmic Viscosurgical
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP840064
Supplement NumberS094
Date Received09/02/2026
Decision Date10/01/2026
Product Code LZP 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a change in the Endotoxin testing program for the subject ophthalmic viscosurgical devices (OVDs), including test article preparation and individual component testing
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