Clareon and Clareon Toric Intraocular Lenses (IOLs)
FDA premarket approval P190018/S001 · decided 2020-07-15
Approval details
- PMA number
- P190018
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Clareon and Clareon Toric Intraocular Lenses (IOLs)
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, LLC
- Date received
- 2020-04-16
- Decision date
- 2020-07-15
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for 3 changes related to the shelf life of the Clareon IOLs: 1) 3 year shelf life labeling for the Clareon and Clareon Toric IOLs presented in the AutonoMe Pre-Loaded Delivery System (Models CNAOTO and CNAOT3-CNAOT9); 2) a revision of the labeled storage condition to 15-30 °C for the Clareon and Clareon Toric IOLs presented in the AutonoMe Pre-Loaded Delivery System (Models CNAOTO and CNAOT3-CNAOT9); and 3) a revision to the ongoing real-time shelf life study protocols to streamline pla
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