BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3231504 · Received July 15, 2013

    Report

    Report Number
    1119421-2013-00770
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER CALLED TO REPORT THAT HE HAD AN INTRAOCULAR LENS (IOL) IMPLANTED IN HIS LEFT EYE. THE DAY AFTER SURGERY HE BEGAN EXPERIENCING DOUBLE VISION. HE FOLLOWED UP WITH HIS SURGEON THAT SAME DAY AND WAS TOLD THAT THE LENS HAD DECENTERED. THREE DAYS AFTER INITIAL IMPLANTATION THE CONSUMER RETURNED TO SURGERY AND HAD THE LENS SEWN INTO THE CORRECT POSITION. THE CONSUMER THEN NOTICED A DECREASE IN VISION AND WAS TOLD HE HAD A "BLOOD CLOT" IN HIS LEFT EYE CAUSED BY THE SEWING OF THE LENS. THE CONSUMER REPORTED THAT OVER TIME THE BLOOD IS SLOWLY CLEARING, AND HIS VISION IS STARTING TO GET BETTER. HE WILL CONTINUE TO HAVE HIS SURGEON MONITOR HIS POSTOPERATIVE COURSE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327758 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MN60AC 12134886

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention