BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON

    MDR report key: 1202197 · Received October 16, 2008

    Report

    Report Number
    MW5008627
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    June 1, 2008
    Report Date
    October 15, 2008
    Manufacturer
    AMO
    Product Code
    LZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    HEALON PRODUCTS DELIVERED WITHOUT BEING PROTECTED FROM EXCESSIVE HEAT. DELIVERIES VIA FED EX CAN BE AS LONG AS 3 DAYS FROM MANUFACTURER DISTRIBUTION CENTER. PACKAGE HAS NO HEAT SENSITIVE DEVICE TO ENSURE HEAT TOLERANCES HAS NOT BEEN EXCEEDED. SUMMER MONTHS OUTSIDE TEMPS EXCEED 100 DEGREES F - TEMP IN BACK OF FED EX TRUCKS CAN EXCEED 120 DEGREES F. WE RECEIVE BOXES THAT ARE HOT TO TOUCH. PRODUCT USED IN CATARACT SURGERIES AND WANT TO INSURE SAFE AND EFFECTIVE AND DRUG NOT DETERIORATED. DIAGNOSIS FOR USE: INTRAOPERATIVE CATARACT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALON NONE LZP AMO NA
    2 HEALON GV NONE LZP AMO NA
    3 HEALON - 5 NONE LZP AMO NA

    Patients

    Seq Age Sex Outcome Treatment
    1