BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPHTALAS 532 EYELITE LASER SYSTEM

    MDR report key: 1761140 · Received July 15, 2010

    Report

    Report Number
    2028159-2010-01183
    Event Type
    Malfunction
    Date Received
    July 15, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 15, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    GEX
    PMA / PMN Number
    K914334
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN RECEIVED AND IN-HOUSE EVALUATION IS IN PROGRESS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CRF 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "PROBE WAS DISCONNECTED:" (MATERIAL SEPARATION). A CUSTOMER REPORTED THE PROBE WAS DISCONNECTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPHTALAS 532 EYELITE LASER SYSTEM LASER INSTRUMENT, SURGICAL, POWERED GEX ALCON - IRVINE TECHNOLOGY CENTER 8065500001 9028950X

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR