BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS

    MDR report key: 5241990 · Received November 22, 2015

    Report

    Report Number
    2523835-2015-00998
    Event Type
    Injury
    Date Received
    November 22, 2015
    Report Date
    November 27, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE
    Product Code
    KYG
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    NO ANGLED POLYMER TIP WAS RETURNED FOR BEING SCRATCHED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A LOT HISTORY REVIEW COULD NOT BE CONDUCTED. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT INFORMATION WAS PROVIDED FOR A LOT RECORD REVIEW, THE ROOT CAUSE FOR CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT THE ANGLED POLYMER TIPS MUST HAVE HAD A BURR ON THEM BECAUSE WHILE USING THE FLAT SURFACE TO POLISH, THE POSTERIOR CAPSULES WERE SCRATCHED AND TORN. THE PRODUCT SAMPLES WERE NOT RETAINED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE. THIS IS ONE OF TWO REPORTS FROM THE SAME FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772117 DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS DEVICE, IRRIGATION, OCULAR SURGERY KYG ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S