BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR ACRYLIC IOL

    MDR report key: 2060353 · Received April 15, 2011

    Report

    Report Number
    2648035-2011-00066
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    February 7, 2011
    Report Date
    March 17, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040/R003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RECEIVED AND INSPECTED UNDER ILLUMINATED 10X MAGNIFICATION. ONE DISTORTED HAPTIC WAS OBSERVED. LENS MET ALL SPECIFICATIONS PRIOR TO RELEASE. BASED ON THE REPORTER'S STATEMENT THAT THERE WAS NO DEFECT WITH THE LENS AND OUR FOLLOW-UP WITH THE ACCOUNT WE HAVE NO REASON TO SUSPECT THE LENS WAS THE CAUSE OF THIS EVENT. ALL INFORMATION AVAILABLE IS INCLUDED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGERY CENTER THAT THE PHYSICIAN DECIDED TO USE A SEW-IN INTRAOCULAR LENS INSTEAD OF THE POSTERIOR CHAMBER LENS HE INITIALLY IMPLANTED. THE LENS WAS REMOVED DURING THE INITIAL PROCEDURE BY ENLARGING THE INCISION, AN ALTERNATE LENS WAS SEWN IN. IN FOLLOW-UP WITH THE NURSE IT WAS LEARNED THE PATIENT HAD A WEAK CAPSULAR BAG THAT COULD NOT SUPPORT THE FIRST IMPLANT AND THERE WAS NO DEFECT WITH THE LENS. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSAR ACRYLIC IOL MONOFOCAL INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other