PMA P060022S002

Device: AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Bausch & Lomb, Inc.
PMA number: P060022
Supplement: S002
Product code: HQL
Decision date: 2009-02-18
Generic name: intraocular lens
Approval order statement: APPROVAL FOR CHANGES TO THE PACKAGING, LABELING AND DESIGN OF THE AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL: AKREOS ADVANCED OPTICS ASPHERIC INTRAOCULAR LENS, AO60. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AKREOS AO MICRO INCISION LENS, MODEL MI60L AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS IN THE VISUAL CORRECTION OF APHAKIA.

Current openFDA PMA Record#

Device: AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Bausch & Lomb, Inc.
PMA number: P060022
Supplement: S002
Product code: HQL
Generic name: intraocular lens
Decision date: 2009-02-18
Decision code: APPR
Date received: 2008-10-24
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGES TO THE PACKAGING, LABELING AND DESIGN OF THE AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL: AKREOS ADVANCED OPTICS ASPHERIC INTRAOCULAR LENS, AO60. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AKREOS AO MICRO INCISION LENS, MODEL MI60L AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS IN THE VISUAL CORRECTION OF APHAKIA.