BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 2844565 · Received November 16, 2012

    Report

    Report Number
    1644019-2012-00202
    Event Type
    Injury
    Date Received
    November 16, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FIELD AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4). THIS REPORT WAS MAILED OF FDA ON: (B)(4) 2012. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGICAL TECHNICIAN REPORTED THAT THE SURGEON OBSERVED A BLUE FIBER AT THE INCISION SITE IN THE EYE OF A PATIENT DURING A POSTOPERATIVE VISIT. THE PATIENT HAD UNDERGONE A CATARACT INTRAOCULAR LENS IMPLANT PROCEDURE. THE SURGEON REMOVED THE RETAINED BLUE FIBER AT THE POSTOPERATIVE VISIT. THIS IS THE SECOND OF TWO REPORTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention