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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 Viscoelastic System.
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP840064
Supplement NumberS092
Date Received02/27/2026
Decision Date08/04/2026
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
An alternate manufacturing site at Alcon Fort Worth Manufacturing located at 6201 South Freeway, Fort Worth, Texas to perform the semiautomatic assembly of filled OVD (PROVISC, VISCOAT, and DUOVISC) syringes and components into blister packs, and packaging.
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