PMA P030002S022

Device: CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S022
Product code: NAA
Decision date: 2010-04-30
Generic name: Lens, intraocular, accommodative
Approval order 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.

Current openFDA PMA Record#

Device: CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S022
Product code: NAA
Generic name: Lens, intraocular, accommodative
Decision date: 2010-04-30
Decision code: APPR
Date received: 2010-03-08
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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.