BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLDMANN APPLANATION

    MDR report key: 3702842 · Received March 24, 2014

    Report

    Report Number
    3702842
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 6, 2014
    Report Date
    March 24, 2014
    Manufacturer
    HAAG-STEIT USA INC.
    Product Code
    HKY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING THE INTRAOCULAR PRESSURE TEST, THE GOLDMANN APPLANATION TONOMETER MEASURING PRISM TIP WAS APPLIED TO BILATERAL EYES TO ASSESS THE INTRAOCULAR PRESSURES. FOLLOWING THIS ASSAY, THE PATIENT BEGAN TO COMPLAIN OF DISCOMFORT AND BLURRED VISION IN BOTH EYES. AFTER AN EXAMINATION OF THE PATIENT'S EYE, IT WAS DETERMINED THE PATIENT SUSTAINED CIRCUMFERENTIAL CORNEA IRRITATIONS, WHICH LINED UP DIRECTLY WITH THE TONOMETER MEASURING PRISM TIP USED IN THE INTRAOCULAR PRESSURE TEST.UPON REVIEW OF THE EVENT AND EXAMINATION OF THE EQUIPMENT, IT WAS NOTED THAT THE TONOMETER MEASURING PRISM TIP USED ON THE PATIENT AND SEVERAL OTHER TONOMETER TIPS APPEAR TO HAVE CRACKING AND EROSION OF THE APPLANATION TIP WHICH COMES IN CONTACT WITH THE EYE. THE STAFF HAS BEEN CLEANING THE TIPS WITH THE MANUFACTURER'S RECOMMENDED CLEANERS (SODIUM HYDROCHLORITE AND HYDROGEN PEROXIDE), YET THE TIPS CONTINUE TO BE DAMAGED DURING THE CLEANING PROCESS. DUE THIS EVENT AND THE QUANTITY OF DAMAGED TONOMETER MEASURING PRISMS, DESPITE FOLLOWING THE MANUFACTURER'S CLEANING INSTRUCTIONS, WE ARE NOW USING DISPOSABLE MEASURING PRISMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173370 GOLDMANN APPLANATION TONOMETER, MANUAL HKY HAAG-STEIT USA INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *