BEUDAMED
    FDA Adverse Event Summary report: N

    VISINE FOR CONTACTS

    MDR report key: 1221785 · Received October 1, 2008

    Report

    Report Number
    2246407-2008-00009
    Date Received
    October 1, 2008
    Date of Event
    January 11, 2008
    Report Date
    January 15, 2008
    Manufacturer
    JOHNSON AND JOHNSON GROUP OF CONSUMER COMPANIES
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR FAILURE ANALYSIS/LABORATORY TESTING. IT CANNOT BE RULED OUT THAT THE PRODUCT MAY HAVE POSSIBLY CAUSED THE EVENT.

    Description of Event or Problem · 1

    A (B) (6) CONSUMER (GENDER UNSPECIFIED) INSTILLED 2 DROPS OF VISINE CONTACT (GLYCERIN, HYDROXYPROPYLMETHYLCELLULOSE) IN EACH EYE WITHIN 20 MINUTES ON (B) (6) 2008 FOR DUST IN EYE AND CONTACT LENS WEARER. AFTER PRODUCT USE, THAT SAME DAY SHE HAD AN ALLERGIC REACTION IN WHICH SHE STATED THAT SHE HAD BURNING AND HALO SIGHT. ACCORDING TO THE CONSUMER, SHE "EVEN HAD HEARING PROBLEMS". ON (B) (6) 2008, SHE WAS SEEN BY AN OPHTHALMOLOGIST WHO TOLD HER THAT A PRESERVATIVE IN THE PRODUCT CAN CAUSE AN ALLERGIC REACTION. PRODUCT USE WAS DISCONTINUED ON (B) (6) 2008. THE EVENT RESOLVED ON (B) (6) 2008. FOLLOW-UP #1: ADDITIONAL INFORMATION RECEIVED ON 25 AUG 2008. QC RESULTS. BASED ON THE INFORMATION GATHERED IN THE INVESTIGATION, THERE IS NO EVIDENCE THAT THE SOURCE OF THE, AS REPORTED IS ASSOCIATED WITH THE (B) (4) MANUFACTURING OR PACKING PROCESS. THE CLINICAL SAFETY DATA INDICATES THAT THE COMPLAINT FOR ALLERGIC REACTION IS CONSISTENT WITH A KNOWN LOW LEVEL INCIDENT RATE ASSOCIATED WITH THE PRODUCT. AS PART OF THE INVESTIGATION, THE LOT DOCKET, WHICH INCLUDES ALL CLEANING, BATCH MAKING, ANALYTICAL TESTING, AND PACKAGING WERE REVIEWED. NO DEVIATIONS OR QUALITY ISSUES ASSOCIATED WITH THIS CLASSIFICATION OF COMPLAINT WERE PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISINE FOR CONTACTS CONTACT LENS PRODUCT LPN JOHNSON AND JOHNSON GROUP OF CONSUMER COMPANIES 0107101

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other