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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.
 
DeviceHealon EndoCoat ™ PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon Duet ™ PRO II Dual Pack Sodium Hya
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP810031
Supplement NumberS083
Date Received07/27/2026
Decision Date10/30/2026
Product Code LZP 
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 new cannula design for use with the Healon EndoCoat™ PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD) in both the individual pack and the Healon Duet™ PRO II Dual Pack
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