BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSTERIOR CHAMBER LENS

    MDR report key: 2841974 · Received November 14, 2012

    Report

    Report Number
    1119421-2012-01412
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    August 15, 2012
    Report Date
    October 15, 2012
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON (B)(4) 2012 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A RISK MANAGEMENT PERSONNEL REPORTED A PT WHO WAS UNDERGOING A LENSECTOMY WITH PLANNED SUTURE PLACEMENT, THAT AFTER MULTIPLE ATTEMPTS TO IMPLANT THE INTRAOCULAR LENS (IOL), THE LENS WAS REMOVED. THE REPORTER INDICATED THE SURGEON NOTED THE HAPTIC WAS DEFECTIVE, THE SUTURE WOULD NOT STAY ON THE HAPTIC, THE LENS COULD NOT BE CENTERED, AND THE LENS WAS REMOVED. THE INCISION WAS CLOSED AND THE PT WILL RETURN FOR LENS REPLACEMENT AT A LATER DATE. 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 CZ70BD 10933409

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention