BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWVUES

    MDR report key: 68492 · Received February 14, 1997

    Report

    Report Number
    1030321-1997-00002
    Event Type
    Injury
    Date Received
    February 14, 1997
    Date of Event
    January 27, 1997
    Report Date
    February 14, 1997
    Manufacturer
    CIBA VISION CORP.
    Product Code
    LPL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SERIOUS INJURY INVOLVING ONE PERSON. ON 1/27/97, PT SAW DR COMPLAINING OF A RED AND IRRITATED RIGHT EYE. DR DIAGNOSED CORNEAL ULCER AND ADIMISTERED CILOXAN AND VOLTAREN. LENS MODEL/WATER CONTENT: 55%; LOT #:6103266; EYE INVOLVED: RIGHT, 8.8, 14.0, 6.00; REFRACTION: MYOPIA: TOTAL DURATION OF USE (IN MONTHS): SINCE 6/93; NUMBER DAYS LENS WORN: 1; LAST VISIT TO DR PRIOR TO SYMPTOMS: 1/20/97; LENS CARE SYSTEM USED: DISINFECTION SOLUTION AND ANOTHER CO'S DAILY CLEANER CHEMICAL; DISINFECTION SYSTEM USED: YES HOMEMADE SALINE USED: NO; DAYS LENS WORN BETWEEN CLEANING & DISINFECTING. 1; DAYS LENS WORN BETWEEN CLEANING & SYMPTOMS; NONE, BRAND NEW; DAYS BETWEEN SYMPTOMS & CALLING DR:2; SELF TREATMENT BY PT: NO; HAND WASHING BEFORE LENS MANIPULATION: YES; ULCER LOCATION 11:O'CLOCK; VISUAL ACUITY BEFORE SYMPTOMS: 20/20; VISUAL ACUITY AFTR SYMPTOMS: 20/20-1; RESULTS OF CULTURE: NONE TAKEN; RESULTS OF CORNEAL BIOPSY AND/OR SCRAPINGS: ONE TAKEN; TREATMENT ADMINISTERED: CILOXIN AND VOLTAREN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWVUES DISPOSABLE SOFT CONTACT LENS LPL CIBA VISION CORP. NA 6103266

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other