AKREOS ADVANCED OPTICS ASPHERIC LENS AND AKROES AO MICRO INCISION LENS
FDA premarket approval P060022/S006 · decided 2010-04-01
Approval details
- PMA number
- P060022
- Supplement
- S006
- Supplement type
- Real-Time Process
- Trade name
- AKREOS ADVANCED OPTICS ASPHERIC LENS AND AKROES AO MICRO INCISION LENS
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2010-01-29
- Decision date
- 2010-04-01
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR DESIGN MODIFICATIONS TO MODEL MI60L AND USE OF MEDICEL VISCOJECT 2.2 LP60430 INSERTER WITH MODEL AO60 AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS IN THE VISUAL CORRECTION OF APHAKIA.
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