BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREVISION

    MDR report key: 400103 · Received June 17, 2002

    Report

    Report Number
    1313525-2002-00009
    Event Type
    Injury
    Date Received
    June 17, 2002
    Report Date
    May 20, 2002
    Manufacturer
    BAUSCH & LOMB INC
    Product Code
    LPL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ARTICLE IN THE BRITISH JOURNAL OF OPHTHALMOLOGY (2002;86:350-362) REPORTS A PT PRESENTED WITH A 2 DAY HISTORY OF RIGHT EYE INJECTION, PAIN, PHOTOPHOBIA, AND DECREASED VISION. PT WAS WEARING CONTACT LENSES ON A DAILY WEAR BASIS BUT CHANGED TO CONTINUOUS WEAR 24 HOURS BEFORE THE ONSET OF THEIR SYMPTOMS. EXAMINATION REVEALED MARKED RIGHT EYE CILLARY INJECTION AND ANTERIOR CHAMBER ACTIVITY WITH CELLS, FLARE, MULTIPLE SCATTERED KPS, AND A SMALL PARACENTRAL EPITHELIAL DEFECT WITH UNDERLYING INFILTRATE. CORNEAL SCRAPINGS CONFIRMED MICROBIAL KERATITIS. TOPICAL CIPROFLOXSCIN 0.3% WAS ADMINISTERED HOURLY WITH THE ADDITION OF TOPICAL FLUOROMETHALINE ACETATE 0.31% Q.I.D. AFTER CLINICAL IMPROVEMENT 24 HRS LATER. ALL TREATMENT WAS TAPERED AND CEASED AFTER 2 WEEKS. THE PT FAILED TO RETURN FOR FOLLOWUP, HOWEVER, IN CONTACT BY PHONE THE PT REPORTED TO THE PRACTITIONER THAT THEIR VISION HAD RETURNED TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUREVISION SOFT CONTACT LENS LPL BAUSCH & LOMB INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention