BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS

    MDR report key: 6185391 · Received December 19, 2016

    Report

    Report Number
    2523835-2016-00934
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    November 21, 2016
    Report Date
    March 3, 2017
    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
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    ONE OPENED IA TIP WAS RECEIVED IN A PLASTIC CONTAINER FOR THE REPORT OF SPUR AT TIP. THE RETURNED SAMPLE WAS VISUALLY INSPECTED. THE TIP, THREAD AND CANNULA WERE CONFORMING. THE HUB AREA WAS NON-CONFORMING; THE HUB WAS TWISTED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, LOT HISTORY AND COMPLAINT HISTORY REVIEWS COULD NOT BE CONDUCTED. A BURR AS DESCRIBED IN THE COMPLAINT CANNOT BE CONFIRMED FROM THIS EVALUATION, THEREFORE, A ROOT CAUSE FOR THE REPORTED ISSUE CANNOT BE DETERMINED FOR THE COMPLAINT AS DESCRIBED BY THE CUSTOMER. A POSSIBLE ROOT CAUSE FOR THE TWISTED HUB SEEN IN THE EVALUATION IS TWISTING OF THE CANNULA/HUB ASSEMBLY WITH GREATER FORCE THAN REQUIRED THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING THE POLISH MODE OF A CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT PROCEDURE THE PATIENT EXPERIENCED A POSTERIOR CAPSULE TEAR. AN ANTERIOR VITRECTOMY WAS PERFORMED AND THE LENS WAS INSERTED INTO THE SULCUS. UPON REVIEW OF THE TIP UNDER A MICROSCOPE THE SURGEON NOTED THAT THE TIP HAD A SMALL SPUR ON IT. THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED FROM A COMPLETED QUESTIONNAIRE INDICATED THAT THE PATIENTS SYMPTOMS HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835463 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 77 YR Other| R