BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA FW

    MDR report key: 590578 · Received April 11, 2005

    Report

    Report Number
    1313525-2005-00006
    Event Type
    Injury
    Date Received
    April 11, 2005
    Date of Event
    June 28, 2004
    Report Date
    December 16, 2004
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    LPZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT SUBMITTED HAD A TYPO IN THE DESCRIPTION OF THE EVENT BELOW. THE INITIAL REPORT INDICATED 2 SELF HEALED ULCERS INSTEAD OF 3. DOCTOR DESCRIBES EVENT AS FOLLOWS: LEFT EYE HURTING FOR ONE WEEK. PROGRESSIVELY WORSENING. SENSITIVE TO LIGHT. CONTACT LENS WAS ONE MONTH OLD. DISCONTINUED WEAR ON 3+ INFERIOR KERATITIS O.S. 3 TO 3+ INJECTED EYE. 3 SELF HEALED ULCERS ON SUPERIOR PART OF EYE.

    Description of Event or Problem · 1

    LEFT EYE HURTING FOR ONE WEEK. PROGRESSIVELY WORSENING SENSITIVE TO LIGHT. CONTACT LENS WAS ONE MONTH OLD. DISCONTINUED WEAR ON_. 3+ INFERIOR KERATITIS O.S. 2 TO 3+ INJECTED EYE. 2 SELF HEALED ULCERS ON SUPERIOR PART OF EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMA FW SOFT CONTACT LENS LPZ BAUSCH & LOMB, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R