BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1081335 · Received July 24, 2008

    Report

    Report Number
    9612169-2008-00003
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    September 27, 2007
    Report Date
    October 11, 2007
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS NOT RETURNED BY THE REPORTING FACILITY. PRODUCT AND BATCH HISTORY RECORDS WERE REVIEWED FOR THE IOL AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THIS LOT NUMBER. ADDITIONAL INFO WAS REQUESTED. A COMPLETED QUESTIONNAIRE WAS REC'D ON 06/24/2008.

    Description of Event or Problem · 1

    A NURSE REPORTED A HAPTIC BROKE OFF THE INTRAOCULAR LENS (IOL) DURING IMPLANTATION. THE IOL WAS REMOVED AND REPLACED WITH A DIFFERENT IOL DURING THE SAME PROCEDURE. IT WAS REPORTED THE SURGICAL INCISION WAS ENLARGED, A VITRECTOMY WAS PERFORMED. THE PT WAS TREATED WITH TOPICAL STEROIDS. THE PT OUTCOME WAS REPORTED AS "POOR" .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SA60AT 20703701

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention