BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADAPT AO MICRO INCISION LENS

    MDR report key: 2010945 · Received March 4, 2011

    Report

    Report Number
    1119279-2011-00056
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    October 20, 2010
    Report Date
    February 3, 2011
    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

    (B)(4) - LABELING ISSUE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT AFTER PERFORMING CATARACT SURGERY WITH IMPLANTATION OF AN AKREOS MI60, THE PATIENT DID NOT ACHIEVE THE TARGET REFRACTION, BUT END REFRACTION WAS -3, 0 DPTR. AN ADD-ON IOL WAS IMPLANTED RESULTING IN EMMETROPIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS ADAPT AO MICRO INCISION LENS INTRAOCULAR LENS HQL BAUSCH + LOMB MI60G 1019705

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other