BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR ACRYLIC IOL

    MDR report key: 2120613 · Received June 10, 2011

    Report

    Report Number
    2648035-2011-00109
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040/R003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE INTRAOCULAR LENS HAS NOT YET BEEN RECEIVED FOR ANALYSIS. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. INFORMATION RECEIVED FROM THE REPORTER SUGGESTS THIS EVENT IS NOT RELATED TO THE DEVICE. IT WAS REPORTED THAT THE INCIDENT WAS CAUSED BY THE DOCTOR'S TECHNIQUE. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RECEIVED AND INSPECTED UNDER ILLUMINATED 10X MAGNIFICATION. RESULTS SHOW HALF OF AN OPTIC WITH ONE DAMAGED HAPTIC. THIS CONDITION IS CONSISTENT WITH A LENS THAT HAS BEEN CUT TO REMOVE FROM THE PATIENT'S EYE. IF FOLLOW-UP WITH THE REPORTER IT WAS LEARNED THE PATIENT REMAINS APHAKIC. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAPSULAR BAG TORE AFTER LENS INSERTION. THE LENS WAS CUT AND REMOVED FROM THE EYE WITHOUT ENLARGEMENT OF THE INCISION. CURRENTLY, THE PATIENT HAS NO LENS. IT WAS REPORTED THAT THE EVENT WAS NOT ATTRIBUTED TO THE LENS AND WAS DUE TO THE DOCTOR'S TECHNIQUE. FOLLOW-UP WITH THE FACILITY ON (B)(6) 2011 INDICATED THAT THE PATIENT HAS NOT BEEN RESCHEDULED FOR ANOTHER LENS PROCEDURE.

    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 80 YR Required Intervention