BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANGO REFLEX

    MDR report key: 8598035 · Received May 9, 2019

    Report

    Report Number
    3013515803-2019-00002
    Event Type
    Injury
    Date Received
    May 9, 2019
    Date of Event
    April 11, 2019
    Report Date
    May 10, 2019
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    UDI-DI
    09342395000298
    PMA / PMN Number
    K021550
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS SOON AS ELLEX MEDICAL BECAME AWARE OF THE INCIDENT, CONSTANT ATTEMPTS HAVE BEEN MADE TO CONTACT THE DOCTOR TO PROVIDE FURTHER DETAILS ON THE EVENT. WITH NO FURTHER INFORMATION AVAILABLE AND BASED ON THE CLINICAL ADVICE PROVIDED, THE INCIDENT IS PROBABLY RELATED TO THE PATIENT HISTORY; PATIENTS WHO ARE PSEUDOPHAKIC AND ESPECIALLY POST YAG CAP, WITH AMORPHOUS OPACITIES IN THE ANTERIOR VITREOUS (BEHIND THE LENS) ARE AT THE HIGHEST RISK FOR IOP SPIKES. CHRONICALLY ELEVATED INTRAOCULAR PRESSURE, IS INCLUDED AS A CONTRAINDICATION FOR THE YAG MODE IN THE OPERATOR MANUAL AND SHOULD HAVE BEEN PROBABLY KNOWN TO THE USER. SUBSEQUENT FINDINGS ON THE DEVICE EVALUATION AND PATIENT STATUS WILL BE UPDATED THROUGH A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    50 MM IOP SPIKE, PERSISTENT WITH DROPS, POST LASER TREATMENT. THIS REPORT IS MADE BY ELLEX WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OF LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387431 TANGO REFLEX OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LT5106-T 09342395000298

    Patients

    Seq Age Sex Outcome Treatment
    1 Other