BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU FRESH MULTI-PURPOSE SOLUTION

    MDR report key: 2633797 · Received June 21, 2012

    Report

    Report Number
    1313525-2012-00016
    Event Type
    Injury
    Date Received
    June 21, 2012
    Date of Event
    May 21, 2012
    Report Date
    May 21, 2012
    Manufacturer
    BAUSCH + LOMB
    Product Code
    LYL
    PMA / PMN Number
    K020802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVAL AND RESULTS FOUND THE SOLUTION MET CHEMICAL SPECS. THERE ARE NO OTHER COMPLAINTS ON THE LOT. DOCTOR WAS UNABLE TO DETERMINE THE EXACT ETIOLOGY AS BOTH THE TEST LENS AND THE SOLUTION WERE NEW TO THE PT. 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 STUDY PT PRESENTED WITH REDNESS, IRRITATION, AND FOREIGN BODY SENSATION OF THE LEFT EYE. EXAMINATION REVEALED CORNEAL INFILTRATES OS>OD AND PT WAS TREATED WITH VIGAMOX IN THE LEFT EYE. LENS WEAR WAS DISCONTINUED AND PT WAS EXITED FROM THE STUDY. PT RETURNED FOR A POST-STUDY VISIT 9 DAYS LATER AND CONDITION HAD RESOLVED. DOCTOR NOTED A SMALL (<1MM) NON-VISUALLY SIGNIFICANT ANTERIOR STROMAL SCAR THAT WAS WITHIN THE CENTRAL 4MM OF THE LEFT CORNEA. THE SCAR WAS NOT PRESENT PRIOR TO THE STUDY. DOCTOR WAS UNABLE TO DETERMINE THE EXACT ETIOLOGY AS BOTH THE TEST LENS AND THE SOLUTION WERE NEW TO THE PT. A CULTURE WAS NOT PERFORMED AS THERE WAS NO SUSPICION OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU FRESH MULTI-PURPOSE SOLUTION LYL BAUSCH + LOMB GB2026

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention