CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
FDA premarket approval P030002 · decided 2003-11-14
Approval details
- PMA number
- P030002
- Trade name
- CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
- Generic name
- Lens, intraocular, accommodative
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2003-01-24
- Decision date
- 2003-11-14
- Days to decision
- 294 days
- Decision code
- APPR
- Product code
- NAA
- Advisory committee
- Ophthalmic
- Expedited review
- Yes
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER IOL. THE DEVICE IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED AND IS INTENDED TO PROVIDE NEAR, INTERMEDIATE AND DISTANCE VISION WITHOUT SPECTACLES. THE CRYSTALENS IOL PROVIDES APPROXIMATELY ONE DIOPTER OF MONOCULAR ACCOMMODATION.
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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 |
| EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION (K111877) | Bausch & Lomb, Inc. | 2012-01-24 |