BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVISTA HYDROPHOBIC ACRYLIC IOL

    MDR report key: 2875043 · Received December 7, 2012

    Report

    Report Number
    1119279-2012-00320
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HAPTIC WAS TORN DURING INJECTION OF AN ENVISTA ((B)(4)) INTRAOCULAR LENS INTO THE PATIENT'S LEFT EYE. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER MODEL LENS WAS SUCCESSFULLY IMPLANTED. THE PATIENT'S PROGNOSIS IS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PLEASE REFERENCE MDR#: 1119279-2012-00321 FOR THE DELIVERY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENVISTA HYDROPHOBIC ACRYLIC IOL HQL/INTRAOCULAR LENS HQL BAUSCH & LOMB MX60US 3224028

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACCUJECT 2.2 DELIVERY DEVICE