BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1905576 · Received November 19, 2010

    Report

    Report Number
    1119421-2010-01301
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 28, 2010
    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
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET ALL RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 11/01/2010, 11/03/2010, 11/04/2010 AND 11/15/2010 BY PHONE, FAX, AND MAIL. ADDITIONAL INFO WAS RECEIVED ON 11/01/2010 AND 11/03/2010 BY PHONE. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT DURING INTRAOCULAR LENS (IOL) SURGERY, A LENS WAS REMOVED. ADDITIONAL INFO WAS RECEIVED FROM A TECH, WHO REPORTED THE LENS WAS REMOVED DUE TO A CAPSULAR BAG TEAR DURING SURGERY. THE PT WAS ORIGINALLY SCHEDULED FOR RETINAL DETACHMENT REPAIR, VITRECTOMY WITH SILICONE OIL, AND CATARACT EXTRACTION WITH IOL PLACEMENT. DURING SURGERY, AFTER THE CAPSULE TORE, THE LENS MIGRATED TO THE VITREOUS AND WAS REMOVED. A DIFFERENT MODEL LENS WAS IMPLANTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 129622

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention