BEUDAMED
    FDA Adverse Event Other Summary report: N

    POSTERIOR CHAMBER LENS

    MDR report key: 1009092 · Received March 6, 2008

    Report

    Report Number
    1119421-2008-00122
    Event Type
    Other
    Date Received
    March 6, 2008
    Date of Event
    January 1, 2007
    Report Date
    February 5, 2008
    Manufacturer
    ALCON RESEARCH, LTD / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P840060
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PROD HISTORY RECORD REVIEW INDICATED THE PROD MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT. ADD'L INFO WAS REQUESTED 02/11/2008, 02/13/2008, 02/025/2008 AND 02/26/2008 BY MAIL, FAX AND PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. A SITE VISIT WAS CONDUCTED BY CLINICAL SCIENCE IN 2008. IT WAS REPORTED THE IOL LOOKED CLEAR AND THE DEPOSITS APPEARED TO BE ON THE LENS AND NOT IN THE LENS. THIS REPORT WAS MAILED TO FDA ON: 03/06/2008.

    Description of Event or Problem · 1

    A SURGERY COORD REPORTS A PT HAS DECREASED VISUAL ACUITY 12 YRS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTEDLY OBSERVED DEPOSITS ON THE ANTERIOR SURFACE OF THE IOL, OF UNK ETIOLOGY. THE SURGEON PLANS TO TRY AND REMOVE THE DEPOSITS WITH LENS RINSING AND/OR PEELING THIS MATERIAL FROM THE LENS. ALSO NOTED WAS THE PT HAS HAD A PREVIOUS YAG PROCEDURE AND PT HAS AN OPENING IN THE POSTERIOR CAPSULE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSTERIOR CHAMBER LENS INTRAOCULAR LENS HQL ALCON RESEARCH, LTD / HUNTINGTON MN30BD 396281

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other