BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SOFT CONTACT LENS

    MDR report key: 2820642 · Received October 31, 2012

    Report

    Report Number
    1313525-2012-00032
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    October 2, 2012
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE ATTACHED ARTICLE REPORTS A STUDY (B)(4) TO DETERMINE THE PREVALENCE OF CONTACT LENS RELATED COMPLICATIONS IN A TERTIARY EYE CARE CENTER IN INDIA. THE ARTICLE REPORTS COMPLICATIONS ASSOCIATED WITH VARIOUS CONTACT LENS PRODUCTS. TABLE 2 SUMMARIZES THE VARIED COMPLICATIONS. TABLE 4 SUMMARIZES THE COMPLICATIONS BY LENS MATERIAL. HOWEVER, THE ARTICLE AND TABLE DO NOT PROVIDE DETAIL TO DETERMINE THE SPECIFIC COMPLICATIONS ASSOCIATED WITH THE IDENTIFIED LENS MATERIALS. THE AUTHOR OF THE ARTICLE WAS CONTACTED FOR ADDITIONAL INFO REGARDING THE CASES OF COMPLICATIONS AND RESPONDED THAT THE CASES WERE NOT CATEGORIZED BY MATERIAL OR BRAND AND THERE IS NO FURTHER INFO. TABLE 2 INDICATES THERE WERE EIGHT CASES OF MICROBIAL KERATITIS. OF THE EIGHT CASES, SEVEN WERE ASSOCIATED WITH THE SOFT CONTACT LENS MATERIALS, AND ONE PT WAS AN RGP WEARER. IT IS NOT KNOW IF THE PTS WERE WEARING A BAUSCH & LOMB LENS. HOWEVER, THE POSSIBILITY OF AN EVENT BEING ASSOCIATED WITH A BAUSCH & LOMB MATERIAL CANNOT BE RULED OUT. THEREFORE, THE EIGHT INFECTIONS KERATITIS CASES ARE BEING REPORTED. PLEASE REFER TO THE ATTACHED ARTICLE FOR FURTHER DISCUSSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SOFT CONTACT LENS NONE LPN BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention