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. |
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Device | TECNIS IOLs |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P980040 |
Supplement Number | S146 |
Date Received | 03/02/2022 |
Decision Date | 03/30/2022 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Expansion of feed rate, tumbling, high-resolution technology and 100-percent in-line image quality measurement system to 3 existing production lines at AMO Puerto Rico facility for manufacturing TECNIS Symfony and TECNIS Symfony Toric II Optiblue Extended Range of Vision Intraocular Lenses (IOL) as well as TECNIS Synergy and TECNIS Synergy Toric II lOLs with TECNIS Simplicity Delivery System. |
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