BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 2073707 · Received April 13, 2011

    Report

    Report Number
    1119421-2011-00400
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO PRODUCT WAS RETURNED FOR ANALYSIS. BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. ACTIONS: THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS FOR THIS LOT. NO FURTHER ACTION IS WARRANTED AT THIS TIME. FINAL COMMENTS: THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT HAS DEVELOPED GLISTENINGS ON THE LENS. THERE HAS BEEN NO IMPACT ON THE PATIENT'S VISION. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE IMPLANT PROCEDURE. THE SURGEON ATTRIBUTES THE PATIENT'S POSTOPERATIVE VISUAL ACUITY OF 20/40+ TO HER PREEXISTING CONDITION OF ADVANCED MACULAR DEGENERATION (AMD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 21000933

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR VIBRAMYCIN