BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCUS DAILIES

    MDR report key: 178076 · Received July 21, 1998

    Report

    Report Number
    1053053-1998-00002
    Event Type
    Injury
    Date Received
    July 21, 1998
    Date of Event
    June 19, 1998
    Report Date
    July 21, 1998
    Manufacturer
    CIBA VISION CORP.
    Product Code
    LPL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SERIOUS INJURY INVOLVING ONE PERSON. PT REPORTED TO DOCTOR ON 6/20/98 WITH REDNESS AND DISCOMFORT IN BOTH EYES. EXAMINATION REVEALED SCARS APPROXIMATELY 3MM ABOVE SUPERIOR LIMBUS APPROXIMATELY 3MM IN LENGTH IN BOTH EYES AND TREATED WITH ANTIBIOTICS PRODUCT TYPE FOCUS DAILIES PARAMETERS : 8.6/13.5/-2.25, 8.6/13.8/-2.75; LOT #: 3002048, 3002112; DIAGNOSIS: CORNEAL SCAR RIGHT EYE; TYPE OF TREATMENT UNK; PROGNOSIS PERMANENT CORNEAL SCAR BOTH EYES, IS FOLLOW-UP NECESSARY: NO, IS FURTHER INVESTIGATION NECESSARY: NO; DATE REPORTED TO COMPLIANCE: 7/10/98; DATE REC'D BY COMPLIANCE: 7/14/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCUS DAILIES DISPOSABLE SOFT CONTACT LENS LPL CIBA VISION CORP. NA 3001048 & 3002112

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other