BEUDAMED
    FDA Adverse Event Other Summary report: N

    OASIS IRIS EXPANDER, 7.0,,

    MDR report key: 3284601 · Received August 5, 2013

    Report

    Report Number
    2083373-2013-00001
    Event Type
    Other
    Date Received
    August 5, 2013
    Date of Event
    February 22, 2013
    Report Date
    August 1, 2013
    Manufacturer
    OASIS MEDICAL, INC.
    Product Code
    HOC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THAT ALONG THE STRETCH OF THE IRIS EXPANDER THERE IS A SPRUE FROM THE INJECTION MOLDING CUT OFF THAT CAUGHT ON THE PATIENT'S ENDOTHELIUM AND CAUSED AN ENDOTHELIAL TEAR. AS REPORTED THE ENDOTHELIAL DESCEMET'S TEAR PERIPHERAL AND NOT SIGNIFICANT WAS IN THE PERIPHERAL CORNEA IN THIS CASE. COMPLICATION REPORTED TO OASIS MEDICAL, INC. ON (B)(6) 2013. THE IRIS EXPANDER AND DISPOSABLE INSERTER USED DURING SURGERY WERE RETURNED FOR EVALUATION. UPON EVALUATION, THE PRODUCT WAS FOUND TO BE IN CONFORMANCE WITH PRODUCT SPECIFICATION REQUIREMENTS. AS A RESULT OF THE REPORTED INCIDENT MODIFICATIONS WERE IDENTIFIED AND IMPLEMENTED TO REDUCE THE ALLOWABLE GATE REMNANT. THE MODIFICATIONS INCLUDED AN IMPROVEMENT TO THE GATE CUTTING TOOLING AND AN IMPROVED TUMBLE POLISH PROCESS. THERE HAVE BEEN NO OTHER REPORTED INCIDENTS OF A SIMILAR NATURE TO DATE FOR THE OASIS IRIS EXPANDER PRODUCT LINE. NOTE: THIS REPORT WAS NOT INITIALLY CONSIDERED A REPORTABLE EVENT AS THE REPORTING PHYSICIAN STATED 'NOT SIGNIFICANT'. DURING A RECENT FDA AUDIT IN JULY 2013 THE REPORTED INCIDENT WAS REVIEWED AND THE AUDITOR RECOMMENDED THAT THE REPORTED EVENT BE SUBMITTED UNDER THE MDR SYSTEM.

    Description of Event or Problem · 1

    REPORTED OBSERVATION: ENDOTHELIUM TEAR. CUSTOMER REPORTED THAT ALONG THE STRETCH OF THE IRIS EXPANDER THERE IS A SPRUE FROM THE INJECTION MOLDING CUT OFF THAT CAUGHT ON THE PATIENT'S ENDOTHELIUM AND CAUSED AN ENDOTHELIAL TEAR. AS REPORTED THE ENDOTHELIAL DESCEMET'S TEAR PERIPHERAL AND NOT SIGNIFICANT WAS IN THE PERIPHERAL CORNEA IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366533 OASIS IRIS EXPANDER, 7.0,, CLIP, IRIS RETRACTOR HOC OASIS MEDICAL, INC. 9700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other