BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALMSCAN AP2000

    MDR report key: 1369516 · Received April 22, 2009

    Report

    Report Number
    MW5010866
    Event Type
    Other
    Date Received
    April 22, 2009
    Date of Event
    April 9, 2008
    Report Date
    April 22, 2009
    Manufacturer
    MICRO MEDICAL DEVICES INC.
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PALMSCAN AP2000 USED TO MEASURE LENS FOR CATARACT SURGERY. PATIENT EXPERIENCED POST SURGERY SIGHT PROBLEMS. LATER DISCOVERED PALMSCAN AP2000 UNIT NOT CONSISTENTLY READING CORRECTLY. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: CATARACT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMSCAN AP2000 OPHTHALMIC ULTRASOUND IYO MICRO MEDICAL DEVICES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other