BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPLETE MULTIPURPOSE EASY RUB

    MDR report key: 1979337 · Received January 28, 2011

    Report

    Report Number
    2020664-2010-00149
    Event Type
    Other
    Date Received
    January 28, 2011
    Date of Event
    August 18, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS, INC.
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ACUITY WAS NOT RECORDED AND CORNEAL EDEMA WAS NOT MENTIONED. THE PCP INDICATED THE EVENT WAS SEVERE IN NATURE AND 'DEFINITELY' RELATED TO USE OF THE DEVICE. HE DID NOT INDICATE THAT TREATMENT WAS REQUIRED TO PRECLUDE PERMANENT INJURY. THE PT DID NOT ALLOW THE MFR TO F/U WITH HIS EYECARE PROFESSIONAL NOR DID HE RETURN THE COMPLAINT UNIT FOR INVESTIGATION. (B)(4) - USED FOR CHEMICAL CONJUNCTIVITIS, PHOTOPHOBIA AND ALLERGIC RHINITIS. A REVIEW OF THE MFG RECORDS FOR THE REPORTED LOT WAS PERFORMED; NO DEVIATIONS WERE NOTED AND PRODUCT MET ALL SPECIFICATIONS. CHEMISTRY EVAL OF A RETAINED SAMPLE IS PENDING.

    Description of Event or Problem · 1

    A MALE PT REPORTED HE EXPERIENCED A BURNING SENSATION AND HIS EYES WERE 'PINK' AFTER USING A NEW BOTTLE OF COMPLETE MULTIPURPOSE SOLUTION EASY RUB FORMULA. HE STORED HIS LENSES IN THE SOLUTION THE NIGHT BEFORE THE EVENT. IN THE MORNING, HE RINSED THE LENSES AND INSERTED THEM AND EXPERIENCED A BURNING SENSATION. HE TRIED RINSING THEM SEVERAL MORE TIMES AND THE BURNING REOCCURRED AND HIS VISION WAS GETTING BLURRY. ON (B)(6) 2010, DURING A F/U PHONE CALL, THE PT REPORTED HE SOUGHT MEDICAL TREATMENT BY HIS PRIMARY CARE PROVIDER (PCP) AS WELL AS HIS EYE CARE PROFESSIONAL. HE STATED HIS PCP TOLD HIM HE HAD CHEMICAL CONJUNCTIVITIS AND ALLERGIC RHINITIS. HE WAS PRESCRIBED NAPHCON A, CLARITIN, AND POLYTRIM EYE DROPS. HE FURTHER INDICATED HIS EYE CARE PROFESSIONAL TOLD HIM HIS LEFT EYE WAS STILL A LITTLE RED AND HIS RIGHT EYE HAD SWELLING OF THE CORNEA. HE WAS PRESCRIBED 'TERRAMYCIN' AND POLYMIXIN ANTIBIOTICS. IN F/U WITH HIS PCP, THE DIAGNOSIS OF CHEMICAL CONJUNCTIVITIS AND ALLERGIC CONJUNCTIVITIS WERE CONFIRMED. NOTES INDICATE THE PT PRESENTED WITH A BURNING SENSATION AND PHOTOPHOBIA AFTER USING CONTACT LENS SOLUTION EARLIER TODAY. UPON EXAMINATION, THE EYELIDS ARE RED AND EDEMATOUS (MODERATE IN SEVERITY), SCLERA IS NORMAL AND CONJUNCTIVA IS INJECTED. IN A F/U VISIT ON (B)(6) 2010, DOCTOR INDICATED CHEMICAL CONJUNCTIVITIS IS MUCH IMPROVED. EYELIDS ARE NORMAL, CONJUNCTIVA IS CLEAR. INSTRUCTED TO CONTINUE CURRENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE MULTIPURPOSE EASY RUB LPN ABBOTT MEDICAL OPTICS, INC. NA AE03500

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other ACUVUE CONTACT LENSES