BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1-DAY ACUVUE

    MDR report key: 1852958 · Received September 29, 2010

    Report

    Report Number
    MW5017654
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC.
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS USED JOHNSON AND JOHNSON 1-DAY ACUVUE MOIST CONTACT LENSES -ETAFILCON A- FOR MORE THAN FOUR YEARS. HE HAS BEEN WEARING SOFT CONTACT LENSES FOR MORE THAN 20 YEARS -- AND DAILY DISPOSABLE CONTACT LENSES FOR MORE THAN 9 YEARS. IN HIS MOST RECENT SUPPLY OF DISPOSABLE LENSES -FOR THE RIGHT EYE-, SOME LENSES HAVE BEEN INCONSISTENTLY THICKER AND/OR DAMAGED ON THE EDGES -- CAUSING IRRITATION TO THE EYE. OTHER LENSES -FOR THE OTHER EYE / DIFFERENT PRESCRIPTION- ARE FINE. THE BC WAS 9.0 DIA WAS 14.2 PRESCRIPTION -3.25 EXPIRATION 01/2015 PRODUCTION 29014401 03C CE0086. DOSE OR AMOUNT: DIA 14.2 / BC 9.0 / -3.25, FREQUENCY: DAILY DISPOSABLE, ROUTE: OTHER. DATES OF USE: DAILY (B)(6) 2010 -- (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: CONTACT LENSES -DAILY DISPOSABLE-. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES. EVENT REAPPEARED AFTER REINTRODUCTION?: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1-DAY ACUVUE DISPOSABLE CONTACT LENSES LPL JOHNSON & JOHNSON VISION CARE, INC. ACUVUE MOIST 29014401 03C

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other