PMA P100016S001

Device: AARIS AND AARIS WITH ADAPTIV OPTICS INTRAOCULAR LENS
Applicant: Carl Zeiss Meditec Production, LLC
PMA number: P100016
Supplement: S001
Product code: HQL
Decision date: 2013-05-28
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: APPROVAL FOR A CHANGE TO THE TRADE NAME OF THE APPROVED LENSES AND LABELING CHANGES TO THE UNIT CARTON, INCLUDING A CHANGE TO THE COLOR SCHEME AND FORMAT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AARIS ACRYLIC INTRAOCULAR LENS (IOL), MODELS EC-3 AND EC-3 PRECISION ASPHERIC LENS (PAL) AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED.

Current openFDA PMA Record#

Device: AARIS AND AARIS WITH ADAPTIV OPTICS INTRAOCULAR LENS
Applicant: Carl Zeiss Meditec Production, LLC
PMA number: P100016
Supplement: S001
Product code: HQL
Generic name: intraocular lens
Decision date: 2013-05-28
Decision code: APPR
Date received: 2013-02-19
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A CHANGE TO THE TRADE NAME OF THE APPROVED LENSES AND LABELING CHANGES TO THE UNIT CARTON, INCLUDING A CHANGE TO THE COLOR SCHEME AND FORMAT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AARIS ACRYLIC INTRAOCULAR LENS (IOL), MODELS EC-3 AND EC-3 PRECISION ASPHERIC LENS (PAL) AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED.