BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3201465 · Received June 28, 2013

    Report

    Report Number
    1033553-2013-00072
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    January 1, 2007
    Report Date
    June 28, 2013
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HYDRACLEAR IS THE TRADE NAME FOR THE PROPRIETARY INTERNAL WETTING AGENT USED IN THE SILICONE HYDROGEL CONTACT LENSES MANUFACTURED BY OUR FIRM. (B)(6): CONTACT LENS-RELATED FUNGAL KERATITIS CASES, RISK FACTORS, AND CAUSATIVE ORGANISMS, PROVIDES THE FOLLOWING INFO. THIS CASE WAS DIAGNOSED IN 2006, THE PT WAS WEARING "ACUVUE OASYS", THE ORGANISM WAS IDENTIFIED AS ASPERGILLUS, THE SOLUTION WAS "RENU", OVERWEAR: NEGATIVE/ EW: NEGATIVE. ACCOMPANYING CONDITION: "VIRAL KERATOCONJUNCTIVITIS". WE CONTACTED ONE OF THE AUTHORS WHO COULD PROVIDE NO ADD'L INFO, BUT STATED THAT "I CAN TELL YOU THAT NONE OF THE LENSES WERE SAVED AS WE JUST DON'T DO THAT". NO ADD'L INFO AVAILABLE. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETING".

    Description of Event or Problem · 1

    THIS MEDWATCH IS TO REPORT ONE OF FIFTEEN CASES OF FUNGAL KERATITIS ASSOCIATED WITH CONTACT LENSES MANUFACTURED BY OUR FIRM. THESE CASES WERE REPORTED IN A RETROSPECTIVE STUDY PUBLISHED BY ELVIN H. YILDIZ, ET AL IN THE JOURNAL "CORNEA" DECEMBER 2010, VOLUME 29, PAGES 1406 - 1411. THE STUDY WAS A RETROSPECTIVE CHART REVIEW OF ALL PTS DIAGNOSED WITH FUNGAL KERATITIS PRESENTING TO THE CORNEA SERVICE AT WILLS EYE INSTITUTE BETWEEN APRIL 1, 1999 AND DECEMBER 31, 2008. ALL PTS WITH CULTURE-POSITIVE FUNGAL INFECTION (DEFINED AS FUNGAL GROWTH ON 2 SEPARATE CULTURE MEDIA), HISTOPATHOLOGICAL DIAGNOSIS OF FUNGAL KERATITIS, AND CULTURE-NEGATIVE CASES THAT WERE DIAGNOSED CLINICALLY ON THE BASIS OF THE RESPONSE TO ANTIFUNGAL TREATMENT AFTER FAILURE OF ANTIBIOTIC THERAPY WERE INCLUDED. SEVENTY-EIGHT EYES OF 76 PTS WERE IDENTIFIED; 28 OF THE CASES WERE ASSOCIATED WITH CONTACT LENS WEAR AND OF THOSE CASES, 15 WERE ASSOCIATED WITH CONTACT LENSES MANUFACTURED BY OUR FIRM. ELEVEN CASES WERE ASSOCIATED WITH ACUVUE 2 BRAND CONTACT LENSES, TWO CASES WITH ACUVUE OASYS BRAND CONTACT LENSES, ONE CASE WAS IDENTIFIED AS "ACUVUE EW" AND ONE CASE WAS IDENTIFIED AS "HYDROCLEAR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296627 UNKNOWN SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R