BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE SQUARE EDGE LENS

    MDR report key: 2212587 · Received August 11, 2011

    Report

    Report Number
    1119279-2011-00149
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LI61SE LENS WAS INSERTED INTO THE PATIENT'S EYE AND IMMEDIATELY REMOVED AS THE HAPTIC BENT INTRAOPERATIVELY. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER IOL OF THE SAME MODEL WAS SUCCESSFULLY IMPLANTED. SUTURES WERE NECESSARY TO CLOSE THE WOUND. PLEASE REFERENCE MDR#: 1119279-2011-00150.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE SQUARE EDGE LENS INTRAOCULAR LENS HQL BAUSCH & LOMB LI61SE 4925213

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EZ-28 DELIVERY SERVICE