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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 OPTIBLUE INTRAOCULAR LENS (IOL) MODEL ZV9003 & 1-PIECE IOL MODEL ZCB00V
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS035
Date Received10/18/2010
Decision Date09/12/2012
Product Code HQL 
Advisory Committee Ophthalmic
Clinical TrialsNCT00747227
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF TWO ADDITIVES (I.E., 2-(3-T-BUTYL-2-HYDROXY-5-VINYL-PHENYL)-5-CHLOROBENZOTRIAZOLE) (UVAM) AND YELLOW DYE) TO THE SENSAR SOFT ACRYLIC IOLS (MODELS ZA9003 AND ZCB00).
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