BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE I/A TIP, DISPOSABLE

    MDR report key: 3941008 · Received June 30, 2014

    Report

    Report Number
    2028159-2014-01197
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 28, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO STRAIGHT SILICONE I/A WAS RETURNED FOR A PC TEAR ONE STERILE LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT MANUFACTURED IN FEBRUARY 2014. (B)(4) COMPONENT TIP LOTS WERE PRESENT WITHIN THIS STERILE LOT. THE DEVICE HISTORY RECORDS FOR THE LOTS WERE REVIEWED. NO ANOMALIES THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER COMPLAINT ISSUE WERE FOUND DURING THE SERVICE HISTORY RECORD REVIEWS. THE PRODUCT WAS RELEASED ACCORDING TO MANUFACTURER'S ACCEPTANCE CRITERIA. A COMPLAINT HISTORY REVIEW INDICATES NO ADDITIONAL COMPLAINTS WERE ASSOCIATED WITH THE STERILE LOT NUMBER. BECAUSE A SAMPLE WAS NOT RETURNED AND THE LOT INFO PROVIDED HAD NO ABNORMALITIES, THE ROOT CAUSE FOR CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A PT EXPERIENCED A POSTERIOR CAPSULAR TEAR DURING A CATARACT PROCEDURE. THE DOCTOR SUSPECTS THE TIP WAS SHARP, HOWEVER, WAS ABLE TO COMPLETE THE CASE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378898 SILICONE I/A TIP, DISPOSABLE NEEDLE, ASPIRATION AND INJECTION DISPOSABLE HQC ALCON PRECISION DEVICE - SINKING SPRING NA 956806M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BAUSCH & LOMB STELLARIS