BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYMER I/A TIP DISPOSABLE

    MDR report key: 3761087 · Received April 10, 2014

    Report

    Report Number
    2523835-2014-00052
    Event Type
    Injury
    Date Received
    April 10, 2014
    Report Date
    March 14, 2014
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED POLYMER I/A TIP SAMPLE WAS RETURNED TO EVAL FOR "POSSIBLE BURR, PC TEAR". THE OPENED TIP WAS EVENTUALLY EXAMINED SUING 3DX MAGNIFICATION AND FOUND TO BE CONFORMING. SIX COMPONENT LOT NUMBERS WERE IDENTIFIED WITH THIS COMPLAINT. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A CUSTOMER PROBLEM WERE FOUND DURING THE REVIEWS. THE PRODUCT WAS RELEASED ACCORDING TO ACCEPTANCE CRITERIA. THE ROOT CAUSE FOR "POSSIBLE BURR, PC TEAR" CANNOT BE DETERMINED FROM THE EVAL BECAUSE THE RETURNED POLYMER I/A TIP AND THE DEVICE HISTORY RECORD REVIEW WAS FOUND TO BE CONFORMING TO SPECS. ALL TIPS ARE 100% VISUALLY INSPECTED BY TRAINED OPERATORS AT THE END OF THE MFG PROCESS PRIOR TO RELEASE OF THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PT EXPERIENCED A POSTERIOR CAPSULE (PC) TEAR DURING A CATARACT WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. THE SURGEON SUSPECTS THAT THERE WAS A BURR ON THE TIP AS THE TIP WAS "GRABBING OR GETTING HOOKED ON SOMETHING" WHICH RESULTED IN THE POSTERIOR CAPSULE TEAR. ADD'L INFO WAS RECEIVED VIA A RETURNED QUESTIONAIRE. THE PC TEAR OCCURRED DURING POLISHING OF THE CAPSULE. DUE TO THE PC TEAR ,THE SURGEON USED A THREE PIECE IOL PLACED IN THE SULCUS. THE PT'S OUTCOME IS NOTED TO HAVE RESOLVED WITH TREATMENT. THIS IS THE FIRST OF TWO REPORTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216213 POLYMER I/A TIP DISPOSABLE NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE HQC ALCON PRECISION DEVICE - SINKING SPRING NA 949050M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SIGNATURE SYSTEM| ENDOCOAT| HEALON| MA60AC THREE PIECE IOL| MONARCH HANDPIECE| INJECTOR