AcrySof Posterior Chamber Single Piece Intraocular Lenses
FDA premarket approval P930014/S111 · decided 2018-04-11
Approval details
- PMA number
- P930014
- Supplement
- S111
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AcrySof Posterior Chamber Single Piece Intraocular Lenses
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2018-03-16
- Decision date
- 2018-04-11
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Implementation of an automated dimensional inspection system as an alternate process for dimensional inspection of AcrySof Intraocular Lenses at the Alcon Ireland manufacturing site.
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