BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYPE7B

    MDR report key: 3900032 · Received May 27, 2014

    Report

    Report Number
    1119421-2014-00390
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    October 29, 2013
    Report Date
    May 6, 2014
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P840060
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. 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. ADDITIONAL INFO WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE POSTERIOR CAPSULE RUPTURED. A BACK-UP LENS WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312015 TYPE7B POSTERIOR CHAMBER, IOL, POLYMETHYLMETHACRYLATE HQL ALCON RESEARCH, LTD. / HUNTINGTON TYPE7B 1214755

    Patients

    Seq Age Sex Outcome Treatment
    1 Other