PMA P030002S014

Device: CRYSTALENS ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (AIOL), MODELS AT-45-HD100, HD500, AND HD520
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S014
Product code: NAA
Decision date: 2008-06-19
Generic name: Lens, intraocular, accommodative
Approval order statement: APPROVAL TO MARKET THE FOLLOWING MODELS IN 0.5 DIOPTER INCREMENTS: MODELS AT-45-HD100 (10 TO 33 DIOPTERS), HD500 (17.0 TO 33.0 DIOPTERS), AND HD520 (10 TO 16.5 DIOPTERS). ADDITIONALLY, APPROVAL TO RECOMMEND USE OF THE STAAR MSI-PR/TR AND MSI-PF/TF INJECTORS WITH MTC-60C CARTRIDGE TO DELIVER THESE LENS MODELS.

Current openFDA PMA Record#

Device: CRYSTALENS ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (AIOL), MODELS AT-45-HD100, HD500, AND HD520
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S014
Product code: NAA
Generic name: Lens, intraocular, accommodative
Decision date: 2008-06-19
Decision code: APPR
Date received: 2007-12-17
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO MARKET THE FOLLOWING MODELS IN 0.5 DIOPTER INCREMENTS: MODELS AT-45-HD100 (10 TO 33 DIOPTERS), HD500 (17.0 TO 33.0 DIOPTERS), AND HD520 (10 TO 16.5 DIOPTERS). ADDITIONALLY, APPROVAL TO RECOMMEND USE OF THE STAAR MSI-PR/TR AND MSI-PF/TF INJECTORS WITH MTC-60C CARTRIDGE TO DELIVER THESE LENS MODELS.