PMA P030002S020

Device: CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S020
Product code: NAA
Decision date: 2011-08-05
Generic name: Lens, intraocular, accommodative
Approval order statement: APPROVAL TO MARKET CRYSTALENS® MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL) WITH A BENZOTRIAZOLE ULTRA-VIOLET (UV) ABSORBER CHROMOPHORE (UVAM). TO BE DESIGNATED AS MODELS AT1UV, AT2UV, HD1UV, HD2UV, AO1UV AND AO2UV.

Current openFDA PMA Record#

Device: CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S020
Product code: NAA
Generic name: Lens, intraocular, accommodative
Decision date: 2011-08-05
Decision code: APPR
Date received: 2009-06-02
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO MARKET CRYSTALENS® MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL) WITH A BENZOTRIAZOLE ULTRA-VIOLET (UV) ABSORBER CHROMOPHORE (UVAM). TO BE DESIGNATED AS MODELS AT1UV, AT2UV, HD1UV, HD2UV, AO1UV AND AO2UV.