BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU (UNKNOWN TYPE)

    MDR report key: 810482 · Received January 25, 2007

    Report

    Report Number
    1313525-2007-00027
    Event Type
    Injury
    Date Received
    January 25, 2007
    Date of Event
    October 29, 2005
    Report Date
    May 22, 2006
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    LPM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAUSCH & LOMB IS UNABLE TO COMPLETE AN INVESTIGATION OF THIS COMPLAINT SINCE NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE HCP REPORTED THAT THE EVENT IS NOT DIRECTLY RELATED TO A SPECIFIC PRODUCT. BASED ON AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED VIA THE FDA MEDWATCH MEDICAL PRODUCTS REPORTING PROGRAM DATED 05/08/2006. PATIENT REPORTS EVENT BEGAN WITH A RECURRING EYE ULCER (TWICE IN NOVEMBER, ONCE IN JANUARY, FEBRUARY AND MARCH). PATIENT RECEIVED TREATMENT IN NOVEMBER: ZYMAR AND LOTEMAX. SUBSEQUENTLY, MEDICAL RECORDS RECEIVED. IN 2005, HCP DIAGNOSED A MARGINAL CORNEAL ULCER, PRESUMED INFECTIOUS, (NOT LOCATED IN CENTRAL 4MM OF CORNEA, NO CULTURE PERFORMED) AND TREATED WITH ZYMAR AND LOTEMAX. HCP FELT PATIENT WAS RECOVERED APPROXIMATELY 2 WEEKS LATER - NO PERMANENT DECREASE IN VISUAL ACUITY. PATIENT ALSO FOLLOWED UP 3 MOS LATER AND CORNEA APPEARED HEALED. NUMEROUS UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN MEDICAL INFORMATION TO VERIFY PATIENT RECEIVED TREAMENT IN NOVEMBER, FEBRUARY AND MARCH. PATIENT LIMITED MEDICAL AUTHORIZATION TO ONE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU (UNKNOWN TYPE) MULTI-PURPOSE SOLUTION FOR SOFT CONTACT LENSES LPM BAUSCH & LOMB, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention