BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 2489111 · Received March 9, 2012

    Report

    Report Number
    1644019-2012-00010
    Event Type
    Injury
    Date Received
    March 9, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 8, 2012
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOM PAK: THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR, THIS IS ONE OF THREE COMPLAINTS REPORTED FOR THIS ISSUE. THE CUSTOM PAK LOT NUMBER FOR THIS COMPLAINT IS NOT KNOWN; THEREFORE, LOT HISTORY AND DHR REVIEW NOT POSSIBLE. A SAMPLE WAS NOT RETURNED FOR THIS COMPLAINT. THIS PRODUCT IS TERMINALLY STERILIZED PRIOR TO RELEASE. UNSPECIFIED SURGICAL BLADE/KNIFE PRODUCT: NO SAMPLES WERE RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OF ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. UNSPECIFIED SURGICAL CONSUMABLE PRODUCT: THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS ONE OF THREE COMPLAINTS REPORTED FOR THIS ISSUE. THE FINISHED GOODS LOT NUMBER FOR THIS COMPLAINT IS NOT KNOWN; THEREFORE, LOT HISTORY AND DHR NOT POSSIBLE. A SAMPLE WAS NOT RETURNED FOR THIS INVESTIGATION. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS OBSERVED ON THE ONE DAY POSTOPERATIVE VISIT FOLLOWING CATARACT SURGERY. ADDITIONAL INFO RECEIVED FROM THE CUSTOMER INDICATES THAT THE SURGEON USED A 2.7 MM CLEAR CORNEAL, TEMPORAL INCISION. ONE DAY POSTOPERATIVE EXAMINATION REVEALED DENSE FIBRIN CONSOLIDATED IN THE ANTERIOR CHAMBER WITH TWO PLUS (++) ANTERIOR CHAMBER CELLS. THIS IS ONE OF FIFTEEN MEDICAL DEVICE REPORTS FOR THIS EVENT, THE FIRST OF THREE INSTRUMENTATION/CUSTOM PAK REPORTS.

    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 79 YR Other CAVI-CLEAN| CASSETTE| CUSTOM PAK| PROVISC| 5% BETADINE| KNIFE| INFINITI OZIL| ZYMAXID| HANDPIECE| BALANCED SALT SOLUTION| (B)(4)| DUOVISC| MONARCH III D CARTRIDGE