BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU FRESH MULTI-PURPOSE SOLUTION

    MDR report key: 2596733 · Received May 30, 2012

    Report

    Report Number
    1313525-2012-00013
    Event Type
    Injury
    Date Received
    May 30, 2012
    Date of Event
    April 15, 2012
    Report Date
    April 27, 2012
    Manufacturer
    BAUSCH + LOMB
    Product Code
    LYL
    PMA / PMN Number
    K020802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVAL AND RESULTS FOUND THE SOLUTION MET CHEMICAL SPECIFICATIONS. DOCTOR DID NOT RELATE THE EVENT TO A SPECIFIC PRODUCT. BASED ON ALL INFO, NO CAUSAL FACTOR CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    DOCTOR REPORTED A PT PRESENTING WITH EYE PAIN IN BOTH EYES. UPON EXAMINATION, PT WAS DIAGNOSED AND TREATED FOR CORNEAL EROSION. THREE WEEKS LATER AT A FOLLOW UP VISIT, THE CORNEAL EROSION WAS IMPROVED. THE INJURY DID NOT PENETRATE THE BOWMAN'S MEMBRANE AND THERE WAS NO PERMANENT DECREASE IN VISUAL ACUITY. THERE WAS A CENTRAL CORNEAL SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU FRESH MULTI-PURPOSE SOLUTION LYL BAUSCH + LOMB GE1134

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4) CONTACT LENSES