BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCUS MONTHLY VISITINT

    MDR report key: 1830982 · Received September 7, 2010

    Report

    Report Number
    9681121-2010-00025
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 19, 2010
    Manufacturer
    PT. CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P820021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE IS CONSIDERED AS A POTENTIAL INFECTIOUS CORNEAL ULCER. CONTRAINDICATIONS (REASONS NOT TO USE) SECTION OF THE PACKAGE INSERT SPECIFICALLY STATES "DO NOT USE FOCUS (VIFILCON A) CONTACT LENSES WHEN ANY OF THE FOLLOWING EXISTS: ... IF EYES BECOME RED OR IRRITATED" AND IN THE WARNINGS SECTION "INSTRUCT PATIENTS AS THE DISPENSING AND SUBSEQUENT VISITS TO IMMEDIATELY REMOVE THEIR LENSES AND PROMPTLY CONTACT THEIR EYE CARE PROFESSIONAL IF THEY SHOULD EXPERIENCE EYE DISCOMFORT, FOREIGN BODY SENSATION, EXCESSIVE TEARING, VISION CHANGES, REDNESS OF THE EYE OR OTHER PROBLEMS WITH THEIR EYES. AN EVALUATION OF THE RETURNED PRODUCT IS UNDERWAY BY MANUFACTURING. (B)(4).

    Description of Event or Problem · 1

    A CONTACT LENS WEARER REPORTED WEARING FOCUS MONTHLY VISITINT LENSES SINCE 2008 AND EXPERIENCING LEFT EYE IRRITATION OF 20 DAYS DURATION ASSOCIATED WITH HER CURRENT SUPPLY. SHE REPORTED SHE SOUGHT CARE FROM A PRACTITIONER AND WAS DIAGNOSED WITH A "CORNEAL ULCER CAUSED BY A LENS CONTAMINATION." FOLLOW-UP INFORMATION TREATMENT CONSISTED OF COMBINATION ANTIBIOTIC/STEROID DROPS (CYLOCORT) FOR 15 DAYS AND THE EVENT HAS COMPLETELY RESOLVED. REQUEST HAS BEEN MADE FOR FURTHER INFORMATION, HOWEVER, NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCUS MONTHLY VISITINT LENSES, SOFT CONTACT, EXTENDED WEAR LPM PT. CIBA VISION BATAM NA 9414117

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE REPORTED