| 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 IOL (SY60WF); Clareon Aspheric UV Absorbing IOL (CC60WF); Clareon Toric Aspheric UV |
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| Generic Name | intraocular lens |
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| Applicant | Alcon Laboratories, LLC
6201 S. Fwy.
Fort Worth, TX 76134 |
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| PMA Number | P190018 |
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| Supplement Number | S048 |
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| Date Received | 01/30/2026 |
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| Decision Date | 04/30/2026 |
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| Product Codes |
HQL MJP |
| Advisory Committee |
Ophthalmic |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
approval application (PMA) 180-day supplement, which requested approval for a new packaging configuration, automation of the primary and secondary packaging processes, and updates to shelf-life and storage conditions of the AcrySof IOLs (storage condition temperatures from 45 °C to 30 °C), and Clareon IOLs (to extend the shelf life from four (4) years to five (5) years at the temperature of 30 °C) in Alcon’s manufacturing facilities in West Virginia, USA and Cork, Ireland. |
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