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 | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon PanOptix Hydrophobic Acrylic IOL |
Generic Name | intraocular lens |
Applicant | Alcon Laboratories, LLC 6201 South Freeway Fort Worth, TX 76134 |
PMA Number | P190018 |
Supplement Number | S014 |
Date Received | 11/05/2021 |
Decision Date | 12/01/2021 |
Product Codes |
HQL MJP |
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 Reduce Clareon Intraocular Lenses (IOLs) dimensional inspection from 100% to a sampling plan for non-toric models. |
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