Clareon Aspheric Hydrophobic Acrylic IOL, Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Preloaded Delivery
FDA premarket approval P190018/S015 · decided 2021-12-21
Approval details
- PMA number
- P190018
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Clareon Aspheric Hydrophobic Acrylic IOL, Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Preloaded Delivery
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2021-11-23
- Decision date
- 2021-12-21
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Change in the microbiological test method for determination of pre-sterilization bioburden, and a change in the organism used to determine the bioburden enumeration correction factor.
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