BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 1-DAY TRUEYE NARAFILCON A

    MDR report key: 3201486 · Received June 28, 2013

    Report

    Report Number
    1033553-2013-00059
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    September 1, 2012
    Report Date
    June 28, 2013
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K073485
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THROUGH PROFESSIONAL AFFAIRS, (B)(4), WE HAVE CONTACTED CORPORATE PROFESSIONAL AFFAIRS FOR THE OPTICAL CHAIN AND HAVE SUBMITTED REQUESTS TO SPEAK WITH THE PATIENT AND FOR THE PATIENT TO CONSENT TO RELEASE OF MEDICAL RECORDS. AS OF TODAY, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. SERIOUS REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS. NO EVALUATION WILL BE PERFORMED. NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    ON (B)(6) 2013, OUR AUTHORIZED REPRESENTATIVE CONTACT IN THE (B)(6) RECEIVED A YELLOW CARD REPORT, 2013/005/029/081/020, SUBMITTED BY AN OPTICIAN. SEE 1033553-2013-00058. THE FOLLOWING DAY, I SPOKE WITH THE REPORTER AND LEARNED OF A SECOND SIMILAR EVENT. THIS PATIENT WAS FIT IN OUR PRODUCT IN (B)(6) 2012. THE PATIENT PRESENTED TO HER GP AND WAS TREATED FOR CONJUNCTIVITIS WITH CHLORAMPHENICOL. WHEN THE SYMPTOMS WORSENED, THE PATIENT WAS REFERRED TO AN OPHTHALMOLOGIST WHO DIAGNOSED FUSARIUM KERATITIS AND ADMITTED THE PATIENT TO (B)(6). THE REPORTER INFORMED THAT THE PATIENT HAS HAD A CORNEAL TRANSPLANT AND HAS HAD HER CRYSTALLINE LENS REMOVED. THE PATIENT IS AWAITING AN INTRAOCULAR LENS FOR IMPLANTATION. THE PATIENT IS REPORTED TO RESIDE ON A FARM WITH LIVESTOCK. THE PATIENT'S FAMILY HAS EXPRESSED TO THE REPORTER THAT THEY SUSPECT DUST FROM HAY SILEAGE MAY HAVE CONTRIBUTED TO THE INFECTION. A FORMAL REQUEST FOR RECORDS WAS SUBMITTED TO THE HOSPITAL BY FAX BUT ACCESS WAS DENIED DUE TO PRIVACY ACT CONCERNS. WE ARE UNABLE TO CONFIRM THIS INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296300 ACUVUE 1-DAY TRUEYE NARAFILCON A SOFT CONTACT LENS (DISPOSABLE) LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| S