BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADVANCE ASPHERIC LENS

    MDR report key: 1893044 · Received October 28, 2010

    Report

    Report Number
    1119279-2010-00075
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    August 12, 2010
    Report Date
    September 29, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THERE WERE NO DISCREPANCIES OR DEVIATIONS IDENTIFIED THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE. THE SURGEON SUSPECTS THAT THE LENS DIOPTER WAS MISLABELED. THE DHR REVIEW INDICATES THAT THE LOT CONFORMED TO SPECIFICATION AT THE TIME OF RELEASE. IN ADDITION, A RETAIN SAMPLE FROM THE SAME LOT, AS THE EXPLANTED LENS WAS MEASURED FOR DIOPTER POWER AND WAS FOUND TO BE WITHIN SPECIFICATIONS, AND NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS MFG LOT.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING UNEVENTFUL CATARACT SURGERY WITH IMPLANTATION OF THE AKREOS ADAPT INTRAOCULAR LENS IN THE RIGHT EYE. POSTOPERATIVELY, THE PT PRESENTED WITH AN UNEXPECTED REFRACTIVE ERROR OF -6.50D. APPROXIMATELY SIX WEEKS POSTOPERATIVELY, THE SURGEON EXPLANTED THE LENS AND REPLACED IT WITH A 21.0 DIOPTER ADAPT INTRAOCULAR LENS. THE PT'S CURRENT VISUAL ACUITY IS + 1.00 - 1.50. PREOPERATIVE VISUAL ACUITY WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS ADVANCE ASPHERIC LENS INTRAOCULAR LENS HQL BAUSCH & LOMB ADAPT 5008552

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention