BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADAPT AO MICRO INCISION LENS

    MDR report key: 1841618 · Received September 16, 2010

    Report

    Report Number
    1119279-2010-00035
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    May 28, 2010
    Report Date
    April 12, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING UNCOMPLICATED CATARACT (PHACO) SURGERY WITH IMPLANTATION OF THE MI60G INTRAOCULAR LENS INTO THE LEFT EYE. APPROXIMATELY THREE WEEKS POSTOPERATIVELY, FIBRIN WAS OBSERVED ON THE POSTERIOR AND ANTERIOR OPTIC. THE PATIENT WAS TREATED WITH STEROIDAL AND AN ANTI-INFLAMMATORY MEDICATION. TWO MONTHS LATER, THERE WERE 2+ CELLS OBSERVED IN THE ANTERIOR CHAMBER AND A YAG CAPSULOTOMY WAS PERFORMED ON THE ANTERIOR AND POSTERIOR CAPSULE. PREOPERATIVELY, THE PATIENT'S VISUAL ACUITY WAS 20/32. POSTOPERATIVELY, THE PATIENT'S VISUAL ACUITY WAS 20/70. THE PATIENT'S CURRENT VISUAL ACUITY IS 20/50. THE LENS REMAINS IMPLANTED AND THE PATIENT CONTINUES TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS ADAPT AO MICRO INCISION LENS INTRAOCULAR LENS HQL BAUSCH & LOMB MI60G2500 1904334

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention