BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1902141 · Received November 10, 2010

    Report

    Report Number
    1119421-2010-01227
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 11, 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
    CT, 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 RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 10/13/2010 AND 10/14/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 10/28/2010. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE LENS WAS REMOVED AND REPLACED. IN A F/U, THE SURGEON CLARIFIED THAT THE CAPSULE RUPTURED AND HE HAD TO SWITCH TO A DIFFERENT LENS MODEL. HE REPORTED THAT THE RUPTURE WAS UNRELATED TO THE INITIAL IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 11019408

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention VISCOAT