BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYSEPT 1-STEP DISINFECTING SOLUTION

    MDR report key: 3954697 · Received July 18, 2014

    Report

    Report Number
    3004178847-2014-00005
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS INC.
    Product Code
    LPN
    PMA / PMN Number
    P850088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT CODE: VISUAL ACUITY WORSENED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED LOT WAS PERFORMED; NO DEVIATION WERE NOTED AND PRODUCT MET ALL SPECIFICATIONS. CHEMISTRY EVALUATION RESULTS OF THE RETURNED AND RETAINED UNIT FROM THE REPORTED LOT WERE WITHIN SPECIFICATIONS. VISUAL EXAMINATION OF THE RETAINED SAMPLE FROM THE SAME LOT WAS WITHIN SPECIFICATIONS; ALL COMPONENTS WERE PRESENT. VISUAL EXAMINATION OF THE KIT RETURNED BY THE CONSUMER DID NOT MEET SPECIFICATIONS. AS THE BOX HAD BEEN OPENED AND USED, IT CONTAINED ONLY TWO BOTTLES OF DISINFECTING SOLUTION (INSTEAD OF THE LABELED 3 BOTTLES). THE NEUTRALIZING TABLETS, DISINFECTION CUP AND DIRECTIONS FOR USE WERE NOT IN THE BOX. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT FROM THE MOTHER OF A MALE PATIENT WHO EXPERIENCED "DAMAGED EYES", LATER REPORTED TO BE "CHEMICAL BURNS" AFTER HIS FIRST TIME USE OF OXYSEPT 1-STEP DISINFECTING SOLUTION AND NOT USING THE ENCLOSED NEUTRALIZING TABLETS PRIOR TO APPLYING THE LENSES TO HIS EYES. THE MOTHER ALSO INDICATED THAT HER SON'S VISION HAD "DETERIORATED NOTICEABLY" AND HE NOW REQUIRES GLASSES/CONTACT LENSES THAT ARE THREE TIMES STRONGER THAN BEFORE THE EVENT. THE REPORTER INDICATED THERE WERE NO DIRECTIONS FOR USE ENCLOSED IN THE BOX. SHE ALSO INDICATED THAT THE DIRECTIONS FOR USE ON THE BOX ARE TOO SMALL. IN FOLLOW UP WITH THE REPORTER IT WAS LEARNED THAT THE PATIENT DID NOT ACTUALLY SEEK MEDICAL TREATMENT FOR THE EVENT BUT SPOKE ON THE TELEPHONE TO A HEALTHCARE PROFESSIONAL WHO REPORTEDLY ADVISED HER TO FLUSH THE EYES WITH "LITRES OF WATER" AND THAT HER SON'S EYES WERE DAMAGED. THE REPORTED WOUND NOT PROVIDE A DATE WHEN HER SON'S SYMPTOMS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422543 OXYSEPT 1-STEP DISINFECTING SOLUTION HYDROGEN PEROXIDE DISINFECTING SOLUTION LPN ABBOTT MEDICAL OPTICS INC. ZM01797

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SOFT CONTACT LENSES (NOT FURTHER SPECIFIED)