BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 2821045 · Received October 25, 2012

    Report

    Report Number
    1644019-2012-00194
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    August 24, 2012
    Report Date
    September 28, 2012
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF (B)(4) 2011 THROUGH (B)(4) 2012; THIS IS THE SECOND COMPLAINT REPORTED FOR THIS ISSUE. NO LOT NUMBERS SPECIFIC TO THIS EVENT WERE PROVIDED; THEREFORE, LOT HISTORY AND DHR REVIEW NOT POSSIBLE. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS NOT KNOWN; A SAMPLE WAS NOT RETURNED FOR INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED TWO CASES OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS). BOTH PTS DIAGNOSED HAD RECEIVED BALANCED SALT SOLUTION (BSS). THE PT REPRESENTED IN THIS REPORT WAS THE SIXTH OF A TOTAL OF ELEVEN PTS HAVING SURGERY ON THAT DAY. A COMPLETED QUESTIONNAIRE WAS RETURNED BY THE SURGEON REPORTING THAT THE PROCEDURE PERFORMED ON THE PT WAS A SCHEDULED CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT. THE SYMPTOMS WERE NOTED AT THE ONE DAY POST-OPERATIVE VISIT. THE PT'S SYMPTOMS RESOLVED AFTER BEING TREATED WITH "INTENSE" TOPICAL STEROIDS. NO CULTURE WERE TAKEN.

    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 58 YR Required Intervention TECNIS LENS| BSS (BALANCED SALT SOLUTION)| MONARCH III| MONARCH II CARTRIDGE| PROPARACAINE 0.5%| PHENYLEPHRINE 2.5%| TROPICAMIDE 1%| CYCLOGYL 1%| VIGAMOX| DUOVISC| OCUTEN 0.03%