BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE CONTACT LENSES-SPECIFIC BRAND UNKNOWN

    MDR report key: 1715052 · Received June 8, 2010

    Report

    Report Number
    1033553-2010-00036
    Event Type
    Injury
    Date Received
    June 8, 2010
    Date of Event
    May 1, 2010
    Report Date
    June 8, 2010
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORNEA, VOL 29, NUMBER 5, 05/2010, PUBLISHED BY (B)(4) "ALTERNARIA AND PAECILOMYCES KERATITIS ASSOCIATED WITH SOFT CONTACT LENS WEAR", ELVIN H. YILDIZ, MD, ET AL. LABELED FOR SINGLE USE AND REUSE. DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS DISCOVERED DURING A ROUTINE LITERATURE SEARCH. THE ARTICLE, "ALTERNARIA AND PAECILOMYCES KERATITIS ASSOCIATED WITH SOFT CONTACT LENS WEAR. CORNEA. 2010;29;564-568. THE ARTICLE REPORTED A SERIES OF 5 PTS WITH SOFT CONTACT LENS (SCL) RELATED FUNGAL KERATITIS CAUSED BY UNUSUAL ORGANISMS DIAGNOSED AT THE AUTHOR'S INSTITUTION IN 2008. PATIENT (PT) 4, A SCL WEARER, WAS REFERRED TO THE AUTHOR'S INSTITUTION FOR A CULTURE OF POSITIVE FUNGAL CORNEAL ULCER OD, WHICH WAS DIAGNOSED A WEEK BEFORE, AFTER A 3-MONTH HISTORY OF SYMPTOMS. THE PT WAS USING ACUVUE, 2 WEEKS FREQUENT REPLACEMENT CONTACT LENSES AND A GENERIC BRAND MULTIPURPOSE SOLUTION MANUFACTURED BY BAUSCH & LOMB INC. ON EXAMINATION, VISUAL ACUITY WAS HAND MOVEMENTS OD AND 20/20 OS. ON SLIT LAMP EXAM, THE PT HAD A 3.5 X 3.7 MM PARACENTRAL INFILTRATE WITH ECTASIA OF THE CENTRAL AREA OF THE ULCERATION IN THE RIGHT EYE. DIFFUSE SURROUNDING CORNEAL EDEMA AND 1 MM HYPOPYON IN THE ANTERIOR CHAMBER WERE PRESENT. PRIOR TREATMENT INCLUDED NATAMYCIN DROPS 5% EVERY HOUR, GATIFLOXACIN DROPS Q2H, FLUCONAZOLE 100 MG PILLS BID. THE PT WAS ADMITTED AND STARTED ON VORICONAZOLE 1% EYE DROPS Q1H AND VORICONAZOLE 200 MG BID BY MOUTH. DESPITE AGGRESSIVE TREATMENT, THE INFECTION PROGRESSED AND AN EMERGENCY PENETRATING KERATOPLASTY WAS PERFORMED 5 DAYS AFTER ADMISSION. THE CORNEA WAS SENT TO PATHOLOGY AND FOR CULTURES. THE PT WAS DISCHARGED ON VORICONAZOLE 1% EYE DROP Q1H, CYCLOSPORINE 0.05% OPHTHALMIC EMULSION QID, GATIFLOXACIN DROPS QID AND VORICONAZOLE 200 MG BID BY MOUTH. PAECILOMYCES WAS IDENTIFIED 6 DAYS AFTER CORNEAL CULTURES. PATHOLOGY OF THE CORNEAL BUTTON DISCLOSED AN INFLAMMATORY INFILTRATE, WHICH INCLUDED A MIXTURE OF POLYMORPHONUCLEAR LEUKOCYTES AND GRANULOMATOUS INFLAMMATION. THE PAS STAIN DISCLOSED RARE FUNGAL ELEMENTS. ONE MONTH POSTOPERATIVELY, THE PT WAS STARTED ON FLUOROMETHOLONE 0.1% DROPS TID. TOPICAL AND ORAL VORICONAZOLE WERE STOPPED 60 DAYS POSTOPERATIVELY. THREE MONTHS POSTOPERATIVELY, THE PT WAS ON CYCLOSPORINE 0.05% BID, FLUOROMETHOLONE 0.1% DROPS BID, FLUOROMETHOLONE 0.1% OINTMENT AT BEDTIME, AND THE VISUAL ACUITY WAS 20/40 IN THE OD AND THE GRAFT REMAINED CLEAR. NO ADDITIONAL INFORMATION WAS PROVIDED. THE AUTHOR CONCLUDED: "IN CONCLUSION, WITH THIS REPORT, WE AIM TO DRAW ATTENTION TO THE INCREASE IN INFECTIOUS KERATITIS CAUSED BY UNUSUAL FUNGAL AGENTS SUCH AS ALTERNARIA AND PAECILOMYCES AS A CAUSE OF SCL-RELATED CORNEAL ULCERS. PHYSICIANS SHOULD CONSIDER THESE UNUSUAL CAUSES OF KERATITIS IN PATIENTS WITH SCL-RELATED CORNEAL ULCERS THAT ARE REFRACTORY TO EMPIRIC BROAD-SPECTRUM ANTIBIOTIC TREATMENT. CULTURES, AND IN SOME CASES REPEAT CULTURES, ARE NECESSARY FOR DIAGNOSES. IT IS IMPORTANT TO REQUEST THAT FUNGAL ISOLATES BE IDENTIFIED." MDRS ARE REVIEWED AT QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE CONTACT LENSES-SPECIFIC BRAND UNKNOWN SOFT CONTACT LENS LPL VISTAKON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R| S BY BAUSCH & LOMB, INC.| GENERIC-BRAND MULTIPURPOSE SOLUTION MANUFACTURED