BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONSEPT 1 STEP DISINFECTING SOLN (DEV 1)

    MDR report key: 3099535 · Received April 29, 2013

    Report

    Report Number
    3004178847-2013-00003
    Event Type
    Other
    Date Received
    April 29, 2013
    Date of Event
    January 15, 2013
    Report Date
    February 18, 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). PRELIMINARY CHEMISTRY TESTING OF THE RETURNED UNIT WAS PERFORMED AT (B)(4) QUALITY CONTROL LAB; RESULTS WERE WITHIN SPECIFICATIONS. ADDITIONAL TESTING WILL BE PERFORMED AT THE MFG SITE. CHEMISTRY EVAL RESULTS FOR THE 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 PRODUCT MET ALL SPECIFICATIONS. THE ROOT CAUSE HAS NOT BEEN ESTABLISHED. 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 FEMALE PT WHO REPORTED SHE EXPERIENCED OCULAR REDNESS AND REPORTED THAT THE 'SURFACE SKIN OF HER EYES HAD COME OFF' AFTER USING CONSEPT 1 STEP. THE PT REPORTED THAT SHE SAW A DOCTOR FIVE TIMES DURING A MONTH PERIOD OF TIME. SHE TREATED WITH LEVOFLOXACIN EYE DROPS, FLUOROMETHOLONE EYE DROPS, FRADIOMYCIN SULFATE / METHYLPREDNISOLONE DROPS (COMBINATION PRODUCT) AND REBAMIPIDE. THE PT STATED THAT THE DOCTOR INDICATED THAT THE HYDROGEN PEROXIDE SOLUTION HAD PROBABLY CAUSED THE EVENT. SHE STATED THAT SHE ADDED THE NEUTRALIZING TABLET AND THE SOLUTION WAS PINK BUT SHE HAD NOT INVERTED THE LENS CUP PRIOR TO INSERTING THE LENSES. THE PT DID NOT REPORT ANY LOSS OF VISION. SEE COMPANION REPORTS: 3004178847-2013-00006 (DEVICE 3) AND 2020664-2013-10001 (DEVICE 2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184187 CONSEPT 1 STEP DISINFECTING SOLN (DEV 1) LPN ABBOTT MEDICAL OPTICS INC. ZK01394

    Patients

    Seq Age Sex Outcome Treatment
    1 Other