BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3122081 · Received May 16, 2013

    Report

    Report Number
    1119421-2013-00534
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ALCON RESEARCH. LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    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. ADDITIONAL INFORMATION WAS REQUESTED. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED FOR AN UNKNOWN REASON. A VITRECTOMY WAS PERFORMED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT, UNKNOWN, TYPE OF LENS. ADDITIONAL INFORMATION WAS RECEIVED. IN THE SURGEON'S OPINION, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216684 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH. LTD. / HUNTINGTON SN60WF 12150709

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention DUOVISC