BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRAMAT LENS CUP

    MDR report key: 1672879 · Received April 29, 2010

    Report

    Report Number
    2020664-2010-00018
    Event Type
    Malfunction
    Date Received
    April 29, 2010
    Date of Event
    February 17, 2010
    Report Date
    February 18, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS, INC.
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK IF THE DEVICE FAILED TO MEET SPECS AS WE HAVE NOT REC'D THE COMPLAINT SAMPLE FOR ANALYSIS, THERE IS NO INFO TO ALLOW IDENTIFICATION OF THE LENS CASE, AND THE LOT NUMBER OF THE DISINFECTING SOLUTION IS UNK. ROOT CAUSE HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    OUR OFFICE IN (B) (4) REC'D A REPORT FROM A MALE PT THAT HIS NON-VENTED CONTACT LENS CASE FOR USE WITH A 3% HYDROGEN PEROXIDE DISINFECTION SYSTEM BURST WHEN HE WAS CARRYING IT IN A BAG. IT CONTAINED ONLY CONSEPT QUICK DISINFECTING SOLUTION. THE PT WAS NOT INJURED. NO FURTHER INFO IS AVAILABLE OR EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRAMAT LENS CUP LPN ABBOTT MEDICAL OPTICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CONSEPT QUICK DISINFECTING SOLUTION