BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2880977 · Received December 14, 2012

    Report

    Report Number
    9612169-2012-00097
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    May 18, 2012
    Report Date
    November 16, 2012
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE LENS MET RELEASE CRITERIA. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE HAS NOTICED THAT WHITES DO NOT LOOK WHITE AND HE HAS LOST DEPTH PERCEPTION. HE REPORTED HE IS A GOLFER, HUNTER, AND HELICOPTER PILOT; AND THESE ISSUES HAVE RESULTED IN DIFFICULTY DOING THESE ACTIVITIES (SUCH AS LANDING AN AIRCRAFT). ADDITIONAL INFORMATION WAS RECEIVED FROM THE OPHTHALMIC ASSISTANT WHO INDICATED THAT AT ONE WEEK POSTOPERATIVELY, THE PATIENT REPORTED "LOSING CLARITY." IN THE SURGEON'S OPINION, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT AND THERE IS NO CLINICAL EVIDENCE TO PROVIDE AN ETIOLOGY FOR THE PATIENT'S SYMPTOMS. THE OUTCOME OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21051922

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other VISCOAT| ZYMAXIDE (DATE OF TX: (B)(6) 2012)| PREDNISONE (DATE OF TX: (B)(6) 2012)| MONARCH HANDPIECE II| MONARCH CARTRIDGE B| BROMDAY (DATE OF TX: (B)(6) 2012)