ACRYSOF Posterior Chamber Intraocular Lens with UltraSert Preloaded Delivery System
FDA premarket approval P930014/S095 · decided 2016-08-11
Approval details
- PMA number
- P930014
- Supplement
- S095
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACRYSOF Posterior Chamber Intraocular Lens with UltraSert Preloaded Delivery System
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2016-08-03
- Decision date
- 2016-08-11
- Days to decision
- 8 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Change in aeration time after EO sterilization for PMMA IOLs and for AcrySof® Posterior Chamber Intraocular Lens with UltraSert Preloaded Delivery System at the Huntington AODC manufacturing facility.
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