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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 Eyhance IOL, TECNIS Eyhance IOL with SmartLOAD Delivery Technology, TECNIS Eyhance IOL with TECNIS Simplicity Del
Generic Nameintraocular lens
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr. Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS117
Date Received06/15/2020
Decision Date12/29/2020
Product Codes HQL MJP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
TECNIS EyhanceTM IOL, Model ICB00; TECNIS EyhanceTM IOL with SmartLOADTM Delivery Technology, Model GIB00; TECNIS EyhanceTM IOL with TECNIS SimplicityTM Delivery System, Model DIB00; TECNIS EyhanceTM Toric II IOLs, Models ICU150-600; and TECNIS EyhanceTM Toric II IOLs with TECNIS SimplicityTM Delivery System, Models DIU150-600, which are an extension of the TECNIS family of one-piece IOLs that incorporate an optical modification.
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