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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.
 
DeviceTECNIS CL Foldable Silicone Intraocular Lens
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP880081
Supplement NumberS043
Date Received05/28/2019
Decision Date06/27/2019
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to revise the TECNIS® CL, Model Z9002, Directions for Use (DFU) to inform the user of the interaction of silicone material with inherent risk factors as follows: Addition of the following to Warning #10: “It has been reported that silicone oil droplets, which remain adherent to the intraocular lens, may reduce the optical quality of the lens and obscure the view of the fundus
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