BEUDAMED
    FDA Adverse Event Other Summary report: N

    GORETEX VENTED LENS CUP (DEVICE 3)

    MDR report key: 3099560 · Received April 29, 2013

    Report

    Report Number
    3004178847-2013-00006
    Event Type
    Other
    Date Received
    April 29, 2013
    Date of Event
    January 5, 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 VISUAL INSPECTION OF THE RETURNED GORETEX VENTED CUP WAS PERFORMED AT THE JAPAN QUALITY CONTROL LAB; RESULTS SHOWED THAT THERE WERE SCRATCHES ON THE GORETEX MEMBRANE. THIS TYPE OF DAMAGE IS USUALLY CAUSED BY THE END USER. IT IS UNK IF THE SCRATCHES CONTRIBUTED TO THE EVENT. ADDITIONAL TESTING WILL BE PERFORMED AT THE MFG SITE. 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: 3004178847-2013-00003 (DEVICE 1) AND 2020664-2013-10001 (DEVICE 2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184792 GORETEX VENTED LENS CUP (DEVICE 3) LPN ABBOTT MEDICAL OPTICS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other