BEUDAMED
    FDA Adverse Event Other Summary report: N

    OASIS IRIS EXPANDER, 7MM

    MDR report key: 2549060 · Received April 3, 2012

    Report

    Report Number
    2083373-2012-00002
    Event Type
    Other
    Date Received
    April 3, 2012
    Date of Event
    March 1, 2012
    Report Date
    April 3, 2012
    Manufacturer
    OASIS MEDICAL, INC.
    Product Code
    HOC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION TO THE TYPE OF REPORT. CHANGED FROM A 5-DAY REPORT TO A 30-DAY REPORT. THE EVENT DOES NOT REQUIRE REMEDIAL ACTION, THIS WAS A TYPOGRAPHICAL ERROR.

    Description of Event or Problem · 1

    REPORTED OBSERVATION: PT DEVELOPED ENDOPHTHALMITIS 4 DAYS POST OP CATARACT SURGERY. PT DEVELOPED HEMORRHAGING IN THE POSTERIOR SEGMENT OF ONE EYE AND EXPERIENCED TEMPORARY LOSS OF VISION. GRAM STAIN TAKEN BY THE ATTENDING PHYSICIAN: NO BACTERIA DETECTED. CULTURE TAKEN BY THE ATTENDING PHYSICIAN: RESULT NOT AVAILABLE AT THE TIME OF REPORTING. COMPLICATION REPORTED TO OASIS MEDICAL, INC ON (B)(4) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASIS IRIS EXPANDER, 7MM CLIP, IRIS RETRACTOR HOC OASIS MEDICAL, INC. 9700 DR0212A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other