Clareon PanOptix Trifocal IOL
FDA premarket approval P190018/S034 · decided 2024-06-11
Approval details
- PMA number
- P190018
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Clareon PanOptix Trifocal IOL
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2024-04-29
- Decision date
- 2024-06-11
- Days to decision
- 43 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- addition of an alternate supplier for the lens stop part in the IOL AutonoMe delivery system
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