PMA P030002S019

Device: CRYSTALENS MODEL AT-45 ACCOMMODATING INTRACULAR LENS (IOL)
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S019
Product code: NAA
Decision date: 2009-06-30
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 HD500 AND HD520 AS FOLLOWS: THE ADDITION OF 0.25 DIOPTER INCREMENTS FOR MODEL HD500 LENSES IN THE +18 TO +22 DIOPTRIC POWER RANGE AND FOR MODEL HD520 LENSES IN THE +16.25 TO +16.75 DIOPTRIC POWER RANGE.

Current openFDA PMA Record#

Device: CRYSTALENS MODEL AT-45 ACCOMMODATING INTRACULAR LENS (IOL)
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S019
Product code: NAA
Generic name: Lens, intraocular, accommodative
Decision date: 2009-06-30
Decision code: APPR
Date received: 2009-05-01
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 HD500 AND HD520 AS FOLLOWS: THE ADDITION OF 0.25 DIOPTER INCREMENTS FOR MODEL HD500 LENSES IN THE +18 TO +22 DIOPTRIC POWER RANGE AND FOR MODEL HD520 LENSES IN THE +16.25 TO +16.75 DIOPTRIC POWER RANGE.