BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADAPT AO MICRO INCISION LENS

    MDR report key: 2201833 · Received August 5, 2011

    Report

    Report Number
    1119279-2011-00146
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RETURNED TO B+L. VISUAL INSPECTION FOUND THE OPTIC TORN AT THE CENTER. ONE HAPTIC WAS TORN OFF AND MISSING. FUNCTIONAL TESTING CANNOT BE PERFORMED DUE TO THE CONDITION OF THE LENS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. INSPECTION AND TEST RECORDS INDICATE THAT THIS LOT CONFORMED TO SPECIFICATION AT THE TIME OF RELEASE. BASED ON THE INFO AVAILABLE, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE SURGEON REPORTS THAT DURING THE INSERTION OF THE MI60LUS INTRAOCULAR LENS, THE PT'S CAPSULE WAS DAMAGED. THE LENS WAS REMOVED, AN ANTERIOR VITRECTOMY WAS PERFORMED, AND A DIFFERENT BAUSCH + LOMB MODEL WAS IMPLANTED. THE PT RECOVERED WELL. REFERENCE MDR #1119279-2011-00147 FOR THE DELIVERY DEVICE USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS ADAPT AO MICRO INCISION LENS INTRAOCULAR LENS HQL BAUSCH & LOMB MI60LUS 1113318

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VISCOJECT 1.8 DELIVERY SYSTEM