BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1407139 · Received June 24, 2009

    Report

    Report Number
    1610287-2009-00019
    Event Type
    Injury
    Date Received
    June 24, 2009
    Date of Event
    May 25, 2009
    Report Date
    May 27, 2009
    Manufacturer
    ALCON - FORTH WORTH/ALCON LABORATORIES INC.
    Product Code
    LPN
    PMA / PMN Number
    K050729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. BATCH RECORDS WERE REVIEWED FOR LOT 141783F AND NO DEVIATIONS WERE IDENTIFIED. THE CHEMISTRY AND MICROBIOLOGY TEST RESULTS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THERE WERE NO SIMILAR REPORTS FOR LOT 141783F. ADDITIONAL INFORMATION WAS REQUESTED FROM THE PATIENT ON 05/27/2009 AND FROM THE PHYSICIAN ON 05/28/209 AND 06/17/2009 AND THE OPTOMETRIST ON 06/04/2009. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON 05/28/2009 AND THE PHYSICIAN AND OPTOMETRIST ON 06/04/2009.

    Description of Event or Problem · 1

    A PATIENT REPORTED THAT HER DAUGHTER'S EYES TURNED "BLOOD RED" AND WERE VERY SENSITIVE TO LIGHT. SHE VISITED AN EMERGENCY ROOM AND WAS TREATED AND RELEASED. SHE THEN TOOK HER DAUGHTER TO AN EYE SPECIALIST AND WAS TOLD THAT SHE HAD SEVERAL CORNEAL ULCERS. SHE STATED THAT HER DAUGHTER WAS TREATED WITH ANTIBIOTICS AND HER EYES ARE FEELING MUCH BETTER. ON 06/04/2009, AN OPHTHALMOLOGIST PROVIDED ADDITIONAL INFORMATION. HE STATED THAT HE DIAGNOSED "MULTIPLE CORNEAL ULCERS" THAT WERE BOTH CENTRAL AND PERIPHERAL. HE TREATED THE PATIENT WITH ANTIBIOTICS AND THE ULCERS WERE RESOLVED. THE PHYSICIAN STATED THAT IT WAS HARD TO SAY IF THE CORNEAL ULCERS WERE CAUSED BY THE PRODUCT BECAUSE, THE CONSUMER HAD GONE CAMPING AND SLEPT IN HER CONTACTS FOR 3 DAYS PRIOR TO THE EVENT. HOWEVER, HE INDICATED IT IS POSSIBLE IT WAS A CONTRIBUTING FACTOR. HE ALSO STATED THAT THE PATIENT DOES HAVE SOME RESIDUAL SUPERFICIAL PUNCTATE KERATITIS SPOTS ON THE CORNEA WHICH HE RELATED TO THE ULCER. HE RECOMMENDED THAT SHE FOLLOW-UP WITH HER OPTOMETRIST. ACCORDING TO THE OPTOMETRIST, AS OF DATE, THE CONSUMER HAD NOT YET SCHEDULED A FOLLOW-UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE REPLENISH LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORTH WORTH/ALCON LABORATORIES INC. NA 141783F

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention ACUVU ADVANCED CONTACTS