BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLINK CONTACTS LUBRICANT EYE DROPS

    MDR report key: 2820868 · Received April 30, 2012

    Report

    Report Number
    3004537773-2012-00003
    Event Type
    Other
    Date Received
    April 30, 2012
    Date of Event
    January 10, 2012
    Report Date
    January 11, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS INC
    Product Code
    LPN
    PMA / PMN Number
    K032030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED LOT WAS PERFORMED; NO RELATED DEVIATIONS WERE NOTED AND PRODUCT MET ALL SPECIFICATIONS. CHEMISTRY EVALUATION RESULTS OF RETAINED UNIT FROM THE REPORTED LOT WERE WITHIN SPECIFICATIONS. MICROBIOLOGY EVALUATION OF RETAINED UNIT FROM THE REPORTED LOT, SHOWED THE SOLUTION TO BE STERILE. THE COMPLAINT UNIT WAS RETURNED BACK ALREADY OPENED; MICROBIOLOGY RESULTS SHOW THAT THE SAMPLE WAS NOT STERILE. THE COMPLAINT UNIT WAS RETURNED BACK ALREADY OPENED; MICROBIOLOGY RESULTS SHOW THAT THE SAMPLE WAS NOT STERILE. INITIAL CHEMICAL EVALUATION OF THE COMPLAINT UNIT CONFIRMED THE PRESENCE OF PARTICULATE MATTER; FURTHER DEVICE EVALUATION IS ONGOING. A ROOT CAUSE HAS NOT BEEN ESTABLISHED. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A (B)(6), FEMALE, PATIENT, REPORTED SHE EXPERIENCED AN 'EYE INFECTION' AFTER USING BLINK CONTACTS. SHE USED THE PRODUCT ONCE A WEEK OR SO FOR SEVERAL MONTHS WITHOUT PROBLEM. IN (B)(6) 2012, SHE BEGAN TO EXPERIENCE ITCHING IN THE RIGHT EYE AND ON (B)(6) 2012, AWOKE AND FOUND HER EYE WAS SWOLLEN SHUT. SHE SAW HER GENERAL PRACTICE PHYSICIAN (GP) WHO TOLD HER SHE HAD A 'STYE THAT HAD GONE CRAZY AND CAUSED AN INFECTION'. SHE WAS PRESCRIBED TOBRAMYCIN 0.3% TO USE FOR ONE WEEK; HER SYMPTOMS HAD MOSTLY RESOLVED WITHIN 24 HOURS. IN FOLLOW UP, THE PATIENT DECLINED TO ALLOW US TO FOLLOW UP WITH HER HEALTH CARE PROFESSIONAL. THE PATIENT INDICATED THAT PRIOR TO THE ONSET OF SYMPTOMS SHE NOTED THAT UPON DISPENSING THE PRODUCT A 'STRING OF BROWN GOOEY SUBSTANCE' CAME OUT OF THE BOTTLE. THE COMPLAINT SAMPLE IS KEPT IN THE PATIENT'S PURSE. PATIENT'S DISPOSABLE LENSES WERE ABOUT 10 DAYS OLD AT THE TIME OF THE EVENT. SHE USES OPTIFREE TO DISINFECT HER LENSES. HER LENS CASE IS ONE YEAR OLD; SHE USES WATER TO CLEAN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLINK CONTACTS LUBRICANT EYE DROPS LPN ABBOTT MEDICAL OPTICS INC AE03124

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other OPTIFREE DISINFECTING SOLUTION