BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCUS DAILIES ONE-DAY

    MDR report key: 728801 · Received June 22, 2006

    Report

    Report Number
    9610813-2006-00001
    Event Type
    Injury
    Date Received
    June 22, 2006
    Date of Event
    November 3, 2005
    Report Date
    May 22, 2006
    Manufacturer
    CIBA VISION GMBH
    Product Code
    LPM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    H6: LOT INFO PROVIDED ON VOL MEDWATCH CONTAINS INSUFFICIENT DIGITS & EXPIRED PRODUCT DATE OF 2/10/2001. REQUEST HAS BEEN MADE TO CLARIFY INFO WITH COMPLAINANT. NO RESPONSE TO DATE. AS THERE WAS NO PRODUCT AND INACCURATE LOT NUMBER PROVIDED, NO DETAILED INVESTIGATION CAN BE PERFORMED

    Description of Event or Problem · 1

    A FOCUS DAILIES WEARER EXPERIENCED INTENSE PAIN AFTER APPLYING RENU MOISTURE LOC SOLUTION IN HER EYES ONE NIGHT. IN THE MORNING, SHE SOUGHT CARE FROM OPHTHALMOLOGIST WHO PRESCRIBED THE SAME SOLUTION. SHE SOUGHT 2ND OPINION AT EYE CENTER WHERE FUSARIUM WAS CULTURED. SHE REPORTS LOSS OF VISION, OD WITH POSSIBLE CORNEAL TRANSPLANT ANTICIPATED. TREATMENT REPORTED AS ANTIFUNGAL MEDICATION. INFO FROM UNIV EYE CENTER STATES PT PRESENTED IN 05 UPON REFERRAL FROM DIFFERNT ECP. CORNEAL ULCER DEVELOPED 3 WEEKS PRIOR. INITIAL TREATMENT CONSISTED OF "HIGH DOSES" OF VIGAMOX, TOBRADEX & EVENTUALLY ACULAR WITH SOME IMPROVEMENT. INCREASING IRRITATION & WORSENING VISION - ACULAR STOPPED. SWITCHED TO FORTIFIED GENTAMCIN & FORTIFIED KEFZOL, & ACYCLOVIR FOR POSSIBLE HERPETIC CENTRAL INFECTIOUS CORNEAL ULCER. CULTURE PERFORMED, NO RESULTS PROVIDED. REDUCED CORNEAL SENSATION OD VS OS. CURRENTLY USES VIGAMOX EVERY 30 MINUTES WHILE AWAKE & TOBRADEX Q.H.S. LAST VISIT 5 DAYS LATER WITH 1 WEEK FOLLOW UP SCHEDULED. PT CANCELLED. FOLLOW UPS. NO FURTHER TREATMENT HAS BEEN PROVIDED. NO RECORD OF FUSARIUM CASE AT THEIR FACILITY. REQUESTS HAVE BEEN MADE FOR ADDL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCUS DAILIES ONE-DAY DAILY WEAR SOFT CONTACT LENSES LPM CIBA VISION GMBH NA 383467

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention NONE REPORTED.