BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS AO MICRO INCISION LENS

    MDR report key: 2051146 · Received April 6, 2011

    Report

    Report Number
    1119279-2011-00061
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 9, 2011
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN OVERLAY COMPARISON OF THE RETURNED IOL FOUND THAT THE LENS MEETS CURRENT STANDARDS. IN ADDITION, A FUNCTIONAL TEST WAS PERFORMED USING A SAMPLE DELIVERY DEVICE. THE LENS WAS LOADED AND DELIVERED WITHOUT DIFFICULTY. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. IN THE SURGEON'S OPINION, THE LIKELY ROOT CAUSE OF THE EVENT IS DUE TO WEAK ZONULES.

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE AKREOS MI60LUS INTRAOCULAR LENS. ACCORDING TO THE SURGEON DURING THE ATTEMPTED INSERTION OF THE LENS INTO THE PATIENT'S RIGHT EYE, THE CAPSULE TORE. THERE WAS LOSS OF VITREOUS AND A VITRECTOMY WAS PERFORMED. THE ORIGINAL INCISION WAS ENLARGED IN ORDER TO REMOVE THE LENS AND AN LI60AO INTRAOCULAR LENS WAS IMPLANTED SUCCESSFULLY. ACCORDING TO THE SURGEON, THE PATIENT IS RECOVERING SLOWLY, BUT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS AO MICRO INCISION LENS INTRAOCULAR LENS HQL BAUSCH & LOMB, INC. MI60LUS 1026447

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention