BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1

    MDR report key: 2831643 · Received November 9, 2012

    Report

    Report Number
    9610813-2012-00013
    Event Type
    Injury
    Date Received
    November 9, 2012
    Report Date
    October 5, 2012
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE LOT NUMBER IS UNK, THEREFORE FURTHER INVESTIGATION CANNOT BE PERFORMED. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A FOLLOW-UP MEDWATCH WILL BE FILED. THIS PRODUCT IS NOT APPROVED OR INTRODUCED INTO COMMERCIAL DISTRIBUTION IN THE UNITED STATES. HOWEVER, THIS MEDWATCH IS BEING FILED BASED ON A SIMILAR PRODUCT DAILIES VISITINT AQUACOMFORT PLUS THAT IS SOLD IN THE UNITED STATES UNDER PMA/510 (K) # K984273. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A PT EXPERIENCED KERATITIS ASSOCIATED WITH CONTACT LENS WEAR. THE COMPLAINT INVOLVES AN OPTICIAN WHO STATES THAT HIS OPHTHALMOLOGIST DIAGNOSED HIM WITH SCLERITIS AND KERATITIS IN THE LEFT EYE. HE WAS PRESCRIBED WITH ANTIBIOTIC TREATMENT FOR 15 DAYS. AFTER THE TREATMENT, HIS EYE WAS STILL RED WHICH RESULTED IN THE OPHTHALMOLOGIST ORDERING HIM TO DISCONTINUE CONTACT LENS WEAR ALTOGETHER. THE OPTICIAN OPTED FOR A SURGICAL PROCEDURE FOR HIS MYOPIA. ADDITIONAL INFORMATION RECEIVED FROM THE PT'S WIFE ON (B)(6) 2012, INDICATES THAT THE PT'S OPHTHALMOLOGIST HAS RELATED THE DIAGNOSIS OF SCLERITIS TO CONTACT LENS WEAR. THE PT'S WIFE FURTHER EXPLAINS HER HUSBAND EXPERIENCED A RAPID ONSET OF RED EYES WHEN WEARING THE DAILIES TOTAL 1 CONTACT LENSES AND BECAUSE OF THIS, CONSULTED WITH AN OPHTHALMOLOGIST (DATE NOT PROVIDED) WHO DIAGNOSED INFECTIONS KERATITIS. THE PT WAS PRESCRIBED ANTIBIOTICS FOR 15 DAYS (ROUTE AND REGIMEN NOT PROVIDED). WHEN TREATMENT WAS COMPLETED, THE PT'S EYES REMAINED RED UNTIL HIS OPERATION. THE PT HAD ALSO UNDERGONE AN OPERATION FOR HIS MYOPIA SINCE THE INITIAL EVENT, AND HAS SINCE RECOVERED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILIES TOTAL 1 LENS, CONTACT (DISPOSABLE) MVN CIBA VISION GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other