BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREVISION TORIC (BALAFILCON A) CONTACT LENS

    MDR report key: 2250088 · Received September 9, 2011

    Report

    Report Number
    1313525-2011-00017
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 23, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LPM
    PMA / PMN Number
    P980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTACT LENS INVOLVED IN THE EVENT WAS NOT RETURNED. HOWEVER, SEALED CONTACT LENSES OF THE SAME LOT WERE RETURNED AND FOUND TO BE WITHIN SPECIFICATIONS. THE LOT DEVICE HISTORY RECORDS WERE REVIEWED AND SHOW THAT ALL REQUIREMENTS WERE MET. MEDICAL DOCUMENTATION FROM THE TREATING DOCTOR HAS NOT BEEN RECEIVED. BASED ON ALL INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    OPTOMETRIST REPORTED THAT A PATIENT WORE LENSES FOR TWO WEEKS AND EXPERIENCED REDNESS AND PAIN IN LEFT EYE. PATIENT WAS DIAGNOSED WITH A PERIPHERAL CORNEAL ULCER BELIEVED TO BE INFECTIOUS AND REFERRED TO A HOSPITAL. A CULTURE WAS PERFORMED BY THE HOSPITAL AND TESTED POSITIVE FOR (B)(6). IT IS UNCLEAR IF THE CULTURE WAS ON THE LENS ON THE CORNEA. PATIENT WAS TREATED WITH GENTAMICIN AND CIPROFLOXACINE. THE PATIENT HAS RESOLVED WITH NO PERMANENT DECREASE IN VISUAL ACUITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUREVISION TORIC (BALAFILCON A) CONTACT LENS LPM BAUSCH & LOMB W18414640

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OPTIONS MULTI-PURPOSE SOLUTION BY COOPERVISION