SOFPORT/SOFLEX INTRAOCULAR LENSES
FDA premarket approval P910061/S022 · decided 2015-11-05
Approval details
- PMA number
- P910061
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SOFPORT/SOFLEX INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb
- Date received
- 2015-10-15
- Decision date
- 2015-11-05
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGING THE TENSILE FORCE TO BREAK SPECIFICATION, ADDING AN ELONGATION TO BREAK SPECIFICATION, AND ADJUSTING THE SAMPLING PLAN FOR OUR HAPTIC MATERIAL.
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| STELLARIS VISION ENHANCEMENT SYSTEM (K133242) | Bausch & Lomb | 2014-02-14 |
| BAUSCH & LOMB INJECTOR SYSTEM (K131958) | Bausch & Lomb | 2014-01-09 |
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| EASY-LOAD LENS DELIVERY SYSTEM (K132481) | Bausch & Lomb | 2013-12-27 |
| CRYSTALSERT DELIVERY SYSTEM (K132593) | Bausch & Lomb | 2013-09-17 |