BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU

    MDR report key: 716047 · Received May 17, 2006

    Report

    Report Number
    MW1039236
    Event Type
    Injury
    Date Received
    May 17, 2006
    Date of Event
    May 8, 2006
    Report Date
    May 17, 2006
    Manufacturer
    BAUSCH AND LOMB
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    USER OF RENU STARTING IN MARCH. DEVELOPED SYMPTOMS OF REDNESS AND IRRITATION. REFERRED FROM OPTOMETRIST TO OPHTHALMOLOGIST. SEEN BY OPHTHALMOLOGIST ON 04/14/2006 EXAM AND CULTURES TAKEN. CIPRO 0.3 AND ZYMAR. SYMPTOMS RESOLVED WITH USE OF THESE DROPS. VISUAL ACUITY DID NOT CHANGE AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU * LPN BAUSCH AND LOMB * *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Disability