BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONSEPT 1-STEP NEUTRALIZING TABLETS

    MDR report key: 2862335 · Received October 30, 2012

    Report

    Report Number
    2020664-2012-10004
    Event Type
    Other
    Date Received
    October 30, 2012
    Date of Event
    June 28, 2012
    Report Date
    July 23, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS INC.
    Product Code
    LPN
    PMA / PMN Number
    P850088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED LOT WAS PERFORMED; NO DEVIATIONS WERE NOTED AND PRODUCT MET ALL SPECIFICATIONS. PHYSICO-CHEMICAL ANALYSIS RESULTS OF BOTH THE RETURNED UNIT AND A RETAINED UNIT OF THE REPORTED LOT ARE CORRECT AND ALL PARAMETERS ARE WITHIN ESTABLISHED ACCEPTANCE CRITERIA. MICROBIOLOGY EVALUATION OF THE RETURNED UNIT SHOWED THE SOLUTION CONFORMED WITH SPECIFICATIONS. MICROBIOLOGY EVALUATION OF A RETAINED UNIT FROM THE REPORTED LOT SHOWED THE SOLUTION CONFORMED WITH SPECIFICATIONS. ROOT CAUSE OF THE REPORTED EVENT WAS NOT ESTABLISHED. ALL PERTINENT INFORMATION HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT IN OUR (B)(4) OFFICE: A FEMALE PATIENT COMPLAINED SHE EXPERIENCED OCULAR PAIN AND PHOTOPHOBIA AFTER WEARING LENSES TREATED WITH CONSEPT 1-STEP. HER EXPERIENCE OCCURRED ABOUT ONE MONTH PRIOR TO HER REPORT. SHE TOLD US SHE HAD NOT HAD ANY PRODUCT PROBLEMS THE TWO WEEKS PRIOR TO HER REPORTED EVENT ON (B)(6) 2012, BUT SHE ALSO REPORTED SHE FELT SOMETHING 'HAZY' IN HER EYES (B)(6) 2012, THE DAY BEFORE HER REPORTED EVENT. ON THE (B)(6), HER SYMPTOMS BUILT UP OVER THE DAY; THE PATIENT SOUGHT TREATMENT AT AN EYE CLINIC NEAR HER WORKPLACE, WAS DIAGNOSED WITH CORNEAL LESIONS, AND WAS PRESCRIBED AN ANESTHETIC AS TEMPORARY TREATMENT. SHE THEN VISITED ANOTHER EYE CLINIC NEAR HER HOME, WHERE SHE WAS DIAGNOSED WITH CORNEAL ABRASIONS (BOTH EYES). HER MEDICAL TREATMENT IS UNKNOWN. AT THAT TIME, THE DOCTOR TOLD HER THAT THE INFLAMMATION OCCURRED ALONG THE EDGE WHERE THE LENS CONTACTED HER EYES, SO HE COULD NOT DECIDE IF HER EXPERIENCE WAS CONTACT LENS OR SOLUTION RELATED. VISUAL ACUITY IN HER LEFT EYE (OS) WAS REPORTEDLY AFFECTED AND IT IS UNKNOWN IF HER EYES HAVE RECOVERED AT THE TIME OF THE REPORT. THE DOCTOR NOTED THAT HE FELT HER VISION OS WILL NOT RECOVER. PRODUCT ANALYSES PERFORMED ARE BASED ON A DETERMINATION THAT THE PORTION OF THE SYSTEM WHICH WOULD MOST REASONABLY BE CONSIDERED 'SUSPECT' WERE IT NOT TO FUNCTION PROPERLY IS THE NEUTRALIZING TABLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSEPT 1-STEP NEUTRALIZING TABLETS LPN ABBOTT MEDICAL OPTICS INC. 39479

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CONSEPT 1-STEP DISINFECTING SOLUTION| GORETEX CUP