CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)
FDA premarket approval P030002/S022 · decided 2010-04-30
Approval details
- PMA number
- P030002
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)
- Generic name
- Lens, intraocular, accommodative
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2010-03-08
- Decision date
- 2010-04-30
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- NAA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO MODIFY THE PHYSICIAN¿S LABELING TO INCLUDE THE ADDITION OF 0.25 DIOPTER INCREMENTS FOR THE CRYSTALENS MODEL AT50AO LENSES IN THE +17 TO +27 DIOPTRIC POWER RANGE AND FOR MODEL AT52AO LENSES IN THE +16 TO +16.75 DIOPTRIC POWER RANGE.
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| BAUSCH & LOMB IOL INJECTOR (K113852) | Bausch & Lomb, Inc. | 2012-09-28 |
| OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION (K112909) | Bausch & Lomb, Inc. | 2012-04-30 |
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