BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE IA TIP, DISPOSABLE

    MDR report key: 3940997 · Received June 30, 2014

    Report

    Report Number
    2028159-2014-01199
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HQC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO STRAIGHT SILICONE I/A TIP WAS RETURNED FOR PC TEAR, WITH A VITRECTOMY PERFORMED. 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. THE COMPLAINT INFORMATION DOES INDICATE THE SURGICAL CENTER WAS AWARE THAT THE I/A TIP HAD BEEN USED MORE THAN 10 TIMES, WHICH THE MAXIMUM NUMBER OF USAGES FOR THE LIMITED USE SILICONE I/A TIP. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING A CATARACT PROCEDURE A PATIENT'S CAPSULAR BAG BROKE. THE PATIENT EXPERIENCED VITREOUS LOSS. THE CASE WAS COMPLETED BY PERFORMING A VITRECTOMY AND INSERTING AN ANTERIOR CHAMBER LENS. DIRECTIONS FOR USE WERE NOT FOLLOWED AS THE SCRUB TECHNICIAN VERIFIED THE TIP HAS BEEN USED MORE THAN TEN TIMES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378924 SILICONE IA TIP, DISPOSABLE NEEDLE, ASPIRATON AND INJECTION, DISPOSABLE HQC ALCON PRECISION DEVICE - SINKING SPRING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BAUSCH AND LOMB STELLARIS