BEUDAMED
    FDA Adverse Event Other Summary report: N

    CVS NO RUB CONTACT LENS SOLUTION

    MDR report key: 498263 · Received October 18, 2003

    Report

    Report Number
    MW1030265
    Event Type
    Other
    Date Received
    October 18, 2003
    Date of Event
    October 16, 2003
    Report Date
    October 18, 2003
    Manufacturer
    CVS
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EYE IRRITATION, PAIN & SWELLING UPON USING CVS NO-RUB CONTACT LENS SOLUTION APPROX 5PM; IMPAIRED VISION DUE TO DEGREE OF SWELLING LASTED 24 HRS. WITH TEARING AND PAIN IN EYE; PERSISTED LONGER THAN WOULD EXPECT FROM AN ALLERGIC REACTION. BURNING, SWELLING AND PAIN IN EYE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/14/03: CVS PHARMACY IS CURRENTLY CONDUCTING AN INVESTIGATION REGARDING SIMILAR COMPLAINTS RECEIVED FOR THE SAME PRODUCT. DOCUMENTATION ASSOCIATED WITH THESE COMPLAINTS IS IN THE PROCESS OF BEING COLLATED AND REVIEWED BY THE CVS QUALITY ASSURANCE FUNCTION. PRELIMINARY FINDINGS APPEAR TO INDICATE THAT THE PRODUCT IS BEING MISUSED BY CONSUMERS, POSSIBLY DUE TO THE WORDING ON THE PRODUCT LABEL AND IN THE LABELING (PACKAGE INSERT). CVS REGULATORY FUNCTION HAS REVIEWED THE LABEL AND LABELING AND FOUND THEM TO BE COMPLIANT WITH ALL THE NECESSARY REQUIREMENTS AS STATED IN 21 CFR. DUE TO THE NUMBER OF COMPLAINTS INVOLVING SIMILAR ADVERSE EFFECTS FROM THE USE OF THE PRODUCT CVS IS INVESTIGATING THE LANGUAGE ON THE LABEL AND LABELING REGARDING USE DIRECTIONS. CVS IS ENCLOSING THE CURRENT LABEL AND LABELING WITH HIGHLIGHTED AREA WHICH CONVEY THE APPROPRIATE WARNINGS, ALONG WITH A COPY OF THE PRODUCT EVALUATION REPORT. ALSO ENCLOSING A COPY OF THE MFR'S 510K AND RELEVANT PRODUCT DATA. AS PART OF THE ONGOING INVESTIGATION CVS IS CONSIDERING REVISING THE WARNING STATEMENT ON THE LABEL-LABELING BY MAKING THE FONT COLOR RED AND PUTTING ADD'L STAPLED WARNING ON THE OPENING OF THE PRIMARY CONTAINER. UPON COMPLETION OF INVESTIGATION CVS WILL FORWARD A FINAL REPORT INDICATING ITS FINDINGS AND CORRECTIVE ACTIONS (IF APPLICABLE) AND COPIES OF ANY REVISED LABELS AND LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVS NO RUB CONTACT LENS SOLUTION RINSING, DISINFECTION, CLEANING SOLUTION LPN CVS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other