BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANORAMIC 200 OPHTHALMOSCOPE

    MDR report key: 1402091 · Received June 11, 2009

    Report

    Report Number
    9617167-2009-00001
    Event Type
    Injury
    Date Received
    June 11, 2009
    Date of Event
    April 13, 2009
    Report Date
    May 14, 2009
    Manufacturer
    OPTOS PLC
    Product Code
    HLI
    PMA / PMN Number
    K983999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OPTOS PLC IS SUBMITTING THIS MDR AS THE MANUFACTURER OF THE SUBJECT DEVICE AND ON BEHALF OF THE INITIAL IMPORTER/DISTRIBUTOR, OPTOS INC. RESULTS: (OTHER) OPTOS SERVICE ENGINEER VISITED SITE IN 2009. IT WAS CONFIRMED THE DEVICE STARTED UP AS EXPECTED. LASER POWER WAS MEASURED AND FOUND TO BE 1472 MICRO WATTS. THIS IS WITHIN SPECIFICATION WHICH HAS A MAXIMUM ALLOWABLE POWER AT THE POINT OF MANUFACTURE OF 1850 MICRO WATTS. THIS DEMONSTRATES THE DEVICE WAS OPERATING AT CLASS I AT THE EYE FOR LASER POWER, A CLASSIFICATION THAT IS CONSIDERED NON HAZARDOUS. THE FIELD SERVICE ENGINEER ALSO DEMONSTRATED THAT THE SAFETY SYSTEM SHUT THE DEVICE DOWN WHEN A FAULT CONDITION WAS INVOKED (THIS INCLUDED SHUTTER REMAINING OPEN WHEN IT SHOULD BE CLOSED AND LASER SCANNING SPEED TOO SLOW). CONSIDERATION WAS ALSO GIVEN TO THE LED PROJECTION SYSTEM FOR PATIENT FIXATION. THE EMISSION FROM THIS SYSTEM DOES NOT POSE ANY PHOTOBIOLOGICAL HAZARD AS PER THE CRITERIA GIVEN IN (PHOTOBIOLOGICAL SAFETY OF LAMPS AND LAMP SYSTEMS). IT IS CONCLUDED THAT THE DEVICE IS WITHIN SPECIFICATION. OPTOS IS EXERCISING AN ABUNDANCE OF CAUTION, IN THAT IT IS REPORTING THIS EVENT GIVEN THE PATIENT STATEMENTS. HOWEVER, NO CONTRIBUTORY FACTOR HAS BEEN DISCOVERED WHICH RELATES TO THE DEVICE.

    Description of Event or Problem · 1

    PATIENT HAD A VISUAL FIELD RED STIMULUS AND RETINAL EXAM. THE FOLLOWING DAY, THE PATIENT PHONED THE SITE TO SAY THAT HE HAD A HEADACHE, PHOTOPHOBIA, PERSISTENT AFTER IMAGE AND DESCRIBED A 'VEIL OVER HIS VISION'. FOLLOW UP CHECKS ON THE PATIENT DID NOT REVEAL ANY PROBLEM BUT THE PATIENT HAS STATED HIS SYMPTOMS PERSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANORAMIC 200 OPHTHALMOSCOPE AT TIME OF 510K, HLI (NEWER CODE MYC) HLI OPTOS PLC P200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability