BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3231475 · Received July 15, 2013

    Report

    Report Number
    1119421-2013-00774
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 14, 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
    HI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. THERE ARE NO OTHER COMPLAINTS REPORTED IN THE LOT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, IT WAS OBSERVED THAT THE LENS WAS DEFECTIVE AND THAT A POSTERIOR CAPSULE TEAR OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326717 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 12200170

    Patients

    Seq Age Sex Outcome Treatment
    1 Other