BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONSEPT QUICK DISINFECTING SOLUTION

    MDR report key: 3099559 · Received April 29, 2013

    Report

    Report Number
    3004178847-2013-00004
    Event Type
    Other
    Date Received
    April 29, 2013
    Report Date
    March 22, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS INC
    Product Code
    LPN
    PMA / PMN Number
    P850088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CONSEPT 1 STEP KIT WAS RETURNED TO THE MFR; IT HAD BEEN OPENED. VISUAL INSPECTION OF THE PACKAGE FOUND THAT THE DIRECTIONS FOR USE WERE MISSING. VISUAL INSPECTION OF A RETAINED SAMPLE FROM THE SAME LOT CONTAINED THE PACKAGE INSERT; IT WAS WITHIN SPECIFICATIONS. CHEMISTRY EVAL RESULTS OF THE COMPLAINT UNIT AND A RETAINED SAMPLE FROM THE SAME LOT WERE WITHIN SPECIFICATIONS. A REVIEW OF THE MFG RECORDS FOR THE REPORTED LOT WAS PERFORMED; NO DEVIATIONS WERE NOTED AND THE PRODUCT MET ALL SPECIFICATIONS. THE OUTSIDE OF THE BOX FOR THIS PRODUCT CONTAINS INSTRUCTIONS FOR USE INCLUDING APPROPRIATE WARNINGS AND PRECAUTIONS. THE BOTTLE CONTAINS INSTRUCTIONS NOT TO USE IT DIRECTLY IN THE EYE OR WITHOUT NEUTRALIZING PRIOR TO INSERTING THE LENS. ALL PERTINENT INFO AVAILABLE TO THE MFR HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    OUR OFFICE IN (B)(6) RECEIVED A REPORT FROM A MALE PT WHO REPORTED HE EXPERIENCED OCULAR PAIN AFTER USING CONSEPT QUICK DISINFECTING SOLUTION AND NOT USING THE NEUTRALIZING SOLUTION PRIOR TO INSERTING HIS LENSES. THE PT SAW HIS DOCTOR AND WAS TOLD THERE WERE SOME SCRATCHES ON HIS EYES. HE WAS TREATED WITH HYALEIN (PURIFIED SODIUM HYALURONATE OPHTHALMIC SOLUTION) AND CRAVIT (LEVOFLOXACIN HYDRATE). AMO EMPLOYEES MET WITH THE REPORTER AND NOTICED THAT HIS EYE DID NOT APPEAR FULLY OPEN (SWOLLEN). IT IS UNK HOW LONG IT TOOK THE PT TO RECOVER FROM THE EVENT; HE INDICATED HE HAD MISSED SEVERAL DAYS OF WORK. THE PT ALSO COMPLAINED THAT THE BOX DID NOT CONTAIN DIRECTIONS FOR USE FOR THE PRODUCT. MFRS NOTE: DIRECTIONS FOR USE ARE PRINTED ON THE OUTSIDE OF THE CARTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184294 CONSEPT QUICK DISINFECTING SOLUTION LPN ABBOTT MEDICAL OPTICS INC ZK03546

    Patients

    Seq Age Sex Outcome Treatment
    1 Other