EN VISTA ONE PEICE HYDROPHOBIC ACRYLIC LENS, MODEL MX60
FDA premarket approval P910056/S010 · decided 2012-05-30
Approval details
- PMA number
- P910056
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EN VISTA ONE PEICE HYDROPHOBIC ACRYLIC LENS, MODEL MX60
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2011-09-12
- Decision date
- 2012-05-30
- Days to decision
- 261 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A MATERIAL CHANGE AND DESIGN MODIFICATIONS (3-PIECE TO 1-PIECE DESIGN AND ASPHERIC SURFACE) TO THE APPROVED BAUSCH & LOMB SILICONE LENS C31UB. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENVISTA ONE-PIECE HYDROPHOBIC ACRYLIC INTRAOCULAR LENS, MODEL MX60 AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM THE CATARACTOUS CRYSTALLINE LENS HAS BEEN REMOVED.
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