BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCUS MONTHLY VISITINT

    MDR report key: 1940807 · Received December 23, 2010

    Report

    Report Number
    9681121-2010-00059
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 26, 2010
    Manufacturer
    PT CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P820021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRAINDICATIONS SECTION OF THE PACKAGE INSERT (PI) SPECIFICALLY STATES DO NOT USE CONTACT LENSES WHEN ANY OF THE FOLLOWING EXIST...IF EYES BECOME RED OR IRRITATED. THE WARNINGS SECTION OF THE PI SPECIFICALLY STATES PATIENTS SHOULD BE ADVISED AT EACH VISIT BY THEIR DISPENSING EYE CARE PROVIDER TO IMMEDIATELY REMOVE THEIR LENSES & PROMPTLY CONTACT THEIR EYE CARE PROVIDER IF THEY SHOULD EXPERIENCE EYE DISCOMFORT, FOREIGN BODY SENSATION, EXCESSIVE TEARING, VISION CHANGES, REDNESS OF THE EYE OR OTHER PROBLEMS WITH THEIR EYES. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A FOLLOW-UP MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    A PATIENT REPORTED REDNESS & PAIN OF FOUR DAYS DURATION, RIGHT EYE, ASSOCIATED WITH WEAR OF FOCUS MONTHLY VISITINT CONTACT LENSES & USE OF VARIOUS BRANDS OF LENS CARE SOLUTION BEFORE SEEKING CARE AT A HOSPITAL BASED OPHTHALMOLOGY DEPARTMENT. THE MEDICAL REPORT INDICATED DIAGNOSIS OF CONTACT LENS INDUCED KERATITIS, RIGHT EYE. CONJUNCTIVAL INJECTION & A CORNEAL INFILTRATE LOCATED 7 O'CLOCK POSITION WERE NOTED. THE ANTERIOR CHAMBER WAS 'DEEP' WITH PRESENCE OF CELLS (TYNDALL POSITIVE). OCULAR FUNDUS & EYE PRESSURE WERE NORMAL, BOTH EYES. UNCORRECTED VISUAL ACUITY REPORTED AS 0,1 RIGHT EYE & 0,05 LEFT EYE. ADMITTED TO HOSPITAL FROM (B)(6) 2010 FOR ANTIBIOTIC & ANTIFUNGAL TREATMENT & CONTINUOUS FOLLOW UP CARE. AT DISCHARGE FROM HOSPITAL ON (B)(6) 2010, CORRECTED VISUAL ACUITY (-4.75 D) REPORTED AS 0,7 RIGHT EYE. FOLLOW UP INFORMATION RECEIVED (B)(6) 2010 FROM THE PATIENT STATED HE WORE THE SAME CONTACT LENS PRESCRIPTION FOR BOTH EYES & USED VARIOUS LENS CARE SOLUTIONS. THE LENSES AND LENS CASE IN USE AT TIME OF EVENT WERE DESTROYED. NO UNUSED SAMPLES OR LOT INFORMATION ARE AVAILABLE FOR EVALUATION. TREATMENT CONSISTED OF POLYSPECTRAN AT, FLOXAL AT & HYLOCOMOD EACH 8XD. PATIENT INSTRUCTED TO DISCONTINUE LENS WEAR 8 WEEKS. REQUEST HAS BEEN MADE FOR ADDITIONAL INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization NONE REPORTED