BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE ADVANCE WITH HYDRACLEAR

    MDR report key: 1715051 · Received June 8, 2010

    Report

    Report Number
    1033553-2010-00037
    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
    K032340
    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 (B)(4) "ALTERNARIA AND PAECILOMYCES KERATITIS ASSOCIATED WITH SOFT CONTACT LENS WEAR", ELVIN H. YILDIZ, MD, ET AL. LABELED FOR 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 LENSE 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 AUTHORS' INSTITUTION IN 2008. PATIENT (PT) 5 PRESENTED TO THE AUTHORS' INSTITUTION'S EMERGENCY ROOM WITH A 1-DAY HISTORY OF A CORNEAL ABRASION IN THE OS WHILE TAKING OUT THE SOFT CONTACT LENS (SCL) AND A CHIEF COMPLAINT OF REDNESS, IRRITATION AND TEARING. THE PT WAS USING 2 WEEK FREQUENT REPLACEMENT ACUVUE ADVANCE LENSES ON A MONTHLY BASIS AND OPTI-FREE REPLENISH MULTIPURPOSE SOLUTION. ON EXAMINATION, THE BEST CORRECTED VISUAL ACUITY (VA) WAS 20/70 OU. BIOMICROSCOPIC EVALUATION REVEALED A 1-5 X 0.5 MM PARACENTRAL EPITHELIAL DEFECT. THE PT WAS STARTED ON MOXIFLOXACIN DROPS Q1H AND BACITRACIN/POLYMYXIN OINTMENT AT BEDTIME. ONE WEEK LATER, IT WAS NOTED THAT THE EPITHELIAL DEFECT HAD PARTIALLY HEALED AND THE MOXIFLOXACIN DROPS WERE TAPERED. WHEN THE PT RETURNED 2 WEEKS LATER, THE VA 20/200 OSS AND A 1.4 X 1.1 MM EPITHELIAL DEFECT SURROUNDED BY A 3.0 X 3.0 MM INFILTRATE WITH INFERIOR THINNING AND A SMALL HYPOPYON WERE PRESENT. CORNEAL SCRAPINGS WERE PERFORMED FOR SMEARS AND CULTURES, THE PREDNISOLONE ACETATE DROPS, WHICH WERE STARTED ELSEWHERE, WERE DISCONTINUED AND THE MOXIFLOXACIN Q1H AND BACITRACIN/POLYMYXIN AT BEDTIME WERE CONTINUED. ONE DAY LATER, CULTURES SHOWED VERY LIGHT GROWTH OF MOLD AND COAGULASE-NEGATIVE (B)(6). THE PT WAS STARTED ON TOPICAL VORICONAZOLE 1% Q1H, VORICONAZOLE 200 MG PILLS BID AND THE MOXIFLOXACIN DROPS WERE DECREASED TO QID. TWO WEEKS LATER, FUNGAL IDENTIFICATION WAS REPORTED AS PAECILOMYCES SPECIES. AFTER AN INITIAL IMPROVEMENT, THERE WAS SUBSEQUENT WORSENING ON THE SAME TREATMENT 2 WEEKS LATER WITH 30% TISSUE LOSS AND A FIBRINOUS REACTION IN THE ANTERIOR CHAMBER. INTRAOCULAR PRESSURE (IOP) WAS 44 MG HG. DORZOLAMIDE HCL-TIMOLOL MALEATE 0.5% TO 2% EYE DROPS AND BRIMONIDINE TARTRATE 0.15% EYE DROPS BID WERE ADDED. FIVE DAYS LATER, A DEEP STROMAL INFILTRATE WITH 70% CORNEAL TISSUE LOSS, AN ENDOTHELIAL PLAQUE, KERATIC PRECIPITATES, AND A 1 MM HYPOPYON WERE NOTED. THE IOP WAS 44 MM HG. REPEAT CORNEAL SCRAPING WAS PERFORMED. THREE DAYS LATER, SLIT LAMP EXAM DEMONSTRATED LESS ANTERIOR CHAMBER REACTION AND A STABLE ULCER. RESULTS OF ANTIFUNGAL SUSCEPTIBILITIES OF THE FIRST CULTURE SHOWED A MINIMUM INHIBITORY CONCENTRATION OF 0.5 UG/ML AT 48 HOURS FOR VORICONAZOLE. IOP WAS 36 MM HG AND ACETAZOLAMIDE 250 MG TABLETS QID WAS ADDED. TWO WEEKS LATER, SLIT LAMP EXAM REVEALED A PERFORATED ULCER WITH A FLAT ANTERIOR CHAMBER. ISOBUTYL CYANOACRYLATE GLUE WAS APPLIED, A BANDAGE CONTACT LENS WAS PLACED AND GATIFLOXACIN OPHTHALMIC SOLUTION 0.3% WAS ADDED. ON DAY LATER, THE ANTERIOR CHAMBER HAD REFORMED, THE INFILTRATE DID NOT EXTEND BEYOND THE GLUE, THE BANDAGE CONTACT LENS WAS IN PLACE, NO HYPOPYON WAS PRESENT, AND THE IOP WAS 20 MM HG. AT THE LAST FOLLOW-UP VISIT, 3 WEEKS AFTER GLUE APPLICATION, THE VISUAL ACUITY WAS 20/200 OS. THE BANDAGE CONTACT LENS WAS IN PLACE, THE INFILTRATE WAS LESS DENSE, THE GLUE WAS GONE, AND THE IOP WAS UNDER CONTROL. NO ADDITIONAL INFORMATION PROVIDED. THE AUTHOR CONCLUDED: "IN CONCLUSION, WITH THIS REPORT, WE AIM TO DRAW ATTENTION TO 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 ADVANCE WITH HYDRACLEAR SOFT CONTACT LENS LPL VISTAKON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention| S OPTI-FREE REPLENISH MULTIPURPOSE SOLUTION