BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACC 27G/20

    MDR report key: 2143072 · Received June 23, 2011

    Report

    Report Number
    2523835-2011-00081
    Event Type
    Injury
    Date Received
    June 23, 2011
    Report Date
    May 24, 2011
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HMX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVAL; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO NOT NUMBER WAS INDICATED FOR THIS COMPLAINT; THEREFORE, THE DEVICE HISTORY RECORD (DHR) FOR THE LOT COULD NOT BE REVIEWED FOR ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT A CANNULA DETACHED WITH FORCE FROM A 3CC SYRINGE WHILE THE SURGEON WAS IRRIGATING INSIDE THE PT'S EYE. AS A RESULT, THE PT EXPERIENCED A RETINAL TEAR. THE CURRENT STATUS OF THE PT IS UNK AT THIS TIME. ADD'L INFO HAS BEEN REQUESTED. THIS IS ONE OF THREE MEDICAL DEVICE REPORTS BEING FILED FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACC 27G/20 CANNULA, OPHTHALMIC HMX ALCON PRECISION DEVICE - SINKING SPRING 8065420120 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention