BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPHTHALAS 532 EYELITE LASER SYSTEM

    MDR report key: 2972464 · Received February 15, 2013

    Report

    Report Number
    2028159-2013-00246
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 8, 2013
    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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE COMPANY REPRESENTATIVE TO ASSIST WITH TROUBLESHOOTING. THE COMPANY REPRESENTATIVE SUGGESTED TO THE CUSTOMER TO USE ANOTHER LIGHT BULB. THE CUSTOMER FOUND A REPLACEMENT LIGHT BULB TO TEST. THE LIGHT BULB WAS REPLACED AND THE ISSUE WAS RESOLVED. THE FACILITY DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE A NONCONFORMING LIGHT BULB. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE SYSTEM'S ILLUMINATION WAS NOT WORKING DURING A PROCEDURE. FOLLOWING A 45 MINUTE DELAY, THE LIGHT BULB WAS REPLACED AND THE SURGERY WAS ABLE TO BE COMPLETED WITH NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69786 OPHTHALAS 532 EYELITE LASER SYSTEM LASER INSTRUMENT, SURGICAL, POWERED GEX ALCON- IRVINE TECHNOLOGY CENTER 8065500001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1