BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE PUREMOIST MPDS

    MDR report key: 3022458 · Received March 22, 2013

    Report

    Report Number
    1610287-2013-00010
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 24, 2013
    Manufacturer
    ALCON - FORT WORTH/ALCON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    K102860
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO SAMPLE WAS RETURNED BY THE CUSTOMER. THE COMPLAINT HISTORY WAS REVIEWED AND THERE WAS NO SIMILAR COMPLAINT REPORTED. REVIEW OF THE COMPOUNDING AND FILLING MANUFACTURER BATCH RECORDS (MBR'S) SHOWS THEM TO BE ACCEPTABLE. A REVIEW OF THE AVAILABLE STABILITY DATA FOR THIS PRODUCT'S FORMULATION LOTS, CURRENTLY ENROLLED IN THE STABILITY PROGRAM, WAS CONDUCTED AND FORMULATION REMAINS WITHIN SPECIFICATION. THE CHEMISTRY AND MICROBIAL FINISHED PRODUCT RESULTS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THE ENVIRONMENTAL, UTILITY, BIOBURDEN, AND SANITATION RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. INCOMING COMPONENT QA INSPECTION TESTING RESULTS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THIS LOT MET ALL RELEASE CRITERIA PRIOR TO PRODUCT RELEASE. THE ROOT CAUSE CANNOT BE DETERMINED FOR THE CHEMICAL BURN; HOWEVER, SOME OF THE EVENTS LISTED IN THE CUSTOMER REPORT ARE CONSISTENT WITH KNOWN ADVERSE EVENTS INDICATED IN THE LABELING. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED AND RECEIVED FROM THE CUSTOMER. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT AFTER USING THIS PRODUCT FOR TWO WEEKS, SHE BEGAN TO HAVE SOME DISCOMFORT WITH HER LENSES TOWARDS THE END OF THE DAY, SO SHE REMOVED HER LENSES WHICH WERE BRAND NEW. AS THE NIGHT WENT ON, HER DISCOMFORT BECAME PAIN AND SHE WAS UNABLE TO OPEN HER EYES. THE CONSUMER REPORTED HER EYES WERE BURNING AND SHE COULD NOT STOP CRYING. SHE HAD HER DAUGHTER TAKE HER TO THE EMERGENCY ROOM WHERE SHE WAS DIAGNOSED WITH SEVERE CORNEAL ABRASIONS. THE NEXT MORNING THE CONSUMER WAS SEEN BY HER EYE CARE PROFESSIONAL AND SHE WAS DIAGNOSED WITH CHEMICAL BURNS. IN A FOLLOW UP, THE CONSUMER REPORTED THAT HER VISION WAS IMPROVING, ESPECIALLY IN HER RIGHT EYE. SHE STILL HAD SOME BLURRY VISION IN HER LEFT EYE. SHE HAD NOT RESUMED WEARING HER CONTACT LENSES. THE CONSUMER PROVIDED ADDITIONAL INFO APPROXIMATELY THREE WEEKS LATER THAT THE EVENT HAD RESOLVED AND SHE HAD RETURNED TO WEARING HER CONTACT LENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119712 OPTI-FREE PUREMOIST MPDS LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORT WORTH/ALCON LABORATORIES, INC. NA 208651F

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR