BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3940274 · Received June 19, 2014

    Report

    Report Number
    1119421-2014-00476
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT. ADDITIONAL INFO WAS REQUESTED BY FAX, MAIL, AND PHONE. A COMPLETED QUESTIONNAIRE WAS RECEIVED (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A COLLEAGUE HAD A PT WITH AN UNEXPECTED POST-OP REFRACTION IN THE RIGHT EYE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. TH PT'S LEFT EYE HAD AN IOL IMPLANT OF THE SAME MODEL AND POWER. THE OUTCOME FOR THE LEFT EYE WAS "EXCELLENT"; THEREFORE, THE SURGEON BELIEVES THE LENS WAS MISLABELED FOR THE IOL USED IN THE RIGHT EYE. ADDITIONAL INFO WAS RECEIVED FROM THE IMPLANTING SURGEON, WHO REPORTED THAT THE EVENT CONTINUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360859 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 12130617

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other TETRACAINE DROPS 0.5%| PERIBULBER BLOCK| PREDFORTE DROPS 1%| WYDASE 150 UNITS/ML| MONARCH III HANDPIECE| MONARCH D CARTRIDGE| LIDOCAINE 1% PF| DUOVISC| EPINEPHRINE 1:1000 ADDED| BSS IRIGATION WITH 0.3%| VIGAMOZ DROPS 0.5%| BRIMONIDONE DROPS 0.2%| ACULAR DROPS 0.5%| LIDOCAINE 4% PF