BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE PUREMOIST MPDS

    MDR report key: 3011156 · Received March 15, 2013

    Report

    Report Number
    1610287-2013-00007
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 14, 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
    NY, 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 WERE THREE SIMILAR COMPLAINTS REPORTED. REVIEW OF THE COMPOUNDING AND FILLING MBR'S SHOWS THEM TO BE ACCEPTABLE. A REVIEW OF THE AVAILABLE STABILITY DATA FOR EVERMOIST PUREMOIST 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 SANITIZATION RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. INCOMING COMPONENT QA INSPECTION TESTING RESULTS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. A RETENTION SAMPLE WAS TESTED FOR OSMOLALITY, COLOR AND CLARITY AND TESTING RESULTS WERE FOUND TO BE ACCEPTABLE. THE LOT MET ALL RELEASE CRITERIA PRIOR TO PRODUCT RELEASE. THE ROOT CAUSE CANNOT BE DETERMINED. THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED THAT A PATIENT WAS SEEN FOR AN EYE EXAMINATION. DURING THE EXAMINATION, THE DOCTOR REMOVED THE PATIENT'S CONTACT LENSES AND PLACED THEM IN A CLEAN LENS CASE WITH THIS PRODUCT. THE OPHTHALMOLOGIST REPORTED THE ONLY MEDICATIONS USED DURING THE EXAMINATION WAS A TOPICAL ANESTHETIC TO PERFORM A TONOMETRY. AFTER THE EXAMINATION, THE CONTACT LENSES WERE REMOVED FROM THE CASE AND RINSED WITH THIS PRODUCT AND REPLACED IN THE PATIENT'S EYES. THE OPHTHALMOLOGIST REPORTED HE WAS WEARING NITRILE EXAM GLOVES WHILE RUBBING THE LENSES WITH THE SOLUTION. THE PATIENT'S WIFE CALLED THE NEXT DAY AND REPORTED THAT SHORTLY AFTER THE EXAMINATION, THE PATIENT CAME DOWN WITH A DEBILITATING HEADACHE AND NAUSEA. SHE REPORTED THE PATIENT WAS IN GREAT DISCOMFORT. THE PATIENT WAS SEEN BY THE OPHTHALMOLOGIST THE NEXT DAY AND HIS CONTACT LENSES WERE REPLACED. IN A FOLLOW UP, THE RECEPTIONIST REPORTED THE PATIENT WAS TREATED IN THE EMERGENCY ROOM FOR HIS HEADACHE AND NAUSEA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111002 OPTI-FREE PUREMOIST MPDS LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORT WORTH / ALCON LABORATORIES, INC. NA 194152F

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BIIOINFINITY TORIC CONTACT LENSES| OPHTHAINE WITH HIGH-MOLECULAR FLOURESCENE| NITRILE EXAM GLOVES