PMA P990013S014

Device: COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
Applicant: Starr Surgical Co.
PMA number: P990013
Supplement: S014
Product code: HQL
Decision date: 2008-01-25
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: APPROVAL FOR PARAMETRIC LOT RELEASE USING EXISTING VALIDATED STEAM STERILIZATION CYCLES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS AND IS INDICATED FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION CATARACT EXTRACTION. THE LENS IS TO BE IMPLANTED IN THE POSTERIOR CHAMBER AND IN THE CAPSULAR BAG THROUGH A TEAR-FREE CAPSULORHEXIS (CIRCULAR TEAR ANTERIOR CAPSULOTOMY).

Current openFDA PMA Record#

Device: COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
Applicant: Starr Surgical Co.
PMA number: P990013
Supplement: S014
Product code: HQL
Generic name: intraocular lens
Decision date: 2008-01-25
Decision code: APPR
Date received: 2007-11-29
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR PARAMETRIC LOT RELEASE USING EXISTING VALIDATED STEAM STERILIZATION CYCLES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS AND IS INDICATED FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION CATARACT EXTRACTION. THE LENS IS TO BE IMPLANTED IN THE POSTERIOR CHAMBER AND IN THE CAPSULAR BAG THROUGH A TEAR-FREE CAPSULORHEXIS (CIRCULAR TEAR ANTERIOR CAPSULOTOMY).