BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE VITRECTOMY LENS: FLAT

    MDR report key: 9488847 · Received December 18, 2019

    Report

    Report Number
    1222074-2019-00049
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA
    Product Code
    HJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT HAS BEEN REQUESTED THAT THE PRODUCT BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. COMPLAINT ARTICLE, A DISPOSABLE VITRECTOMY LENS, WAS RECEIVED. THE PRODUCT WAS PROVIDED IN A BLISTER WITHOUT A LID. VISUAL INSPECTION SHOWED THAT ALL SURFACE OF THE LENS WAS COVERED WITH DUST. MOREOVER, A WHITE DRY RESIDUE WAS IDENTIFIED ON THE SIDE OF THE LENS. AS THE ORIGIN OF THE RESIDUE COULD NOT BE CLEARLY DETERMINED WITHIN D.O.R.C., WE SENT THE LENS TO SGS LABORATORY IN BELGIUM FOR ANALYSIS. AS SOON AS RESULTS ARE AVAILABLE, THE ROOT CAUSE INVESTIGATION WILL BE CONTINUED.

    Additional Manufacturer Narrative · 0

    IT HAS BEEN REQUESTED THAT THE PRODUCT BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. COMPLAINT ARTICLE, A DISPOSABLE VITRECTOMY LENS, WAS RECEIVED. THE PRODUCT WAS PROVIDED IN A BLISTER WITHOUT A LID. VISUAL INSPECTION SHOWED THAT ALL SURFACE OF THE LENS WAS COVERED WITH DUST. MOREOVER, A WHITE DRY RESIDUE WAS IDENTIFIED ON THE SIDE OF THE LENS. AS THE ORIGIN OF THE RESIDUE COULD NOT BE CLEARLY DETERMINED WITHIN D.O.R.C., WE SENT THE LENS TO SGS LABORATORY IN BELGIUM FOR ANALYSIS. AS SOON AS RESULTS ARE AVAILABLE, THE ROOT CAUSE INVESTIGATION WILL BE CONTINUED.

    Description of Event or Problem · 0

    DRIED RESIDUE COATING ON SURFACE OF LENS.

    Description of Event or Problem · 0

    DRIED RESIDUE COATING ON SURFACE OF LENS.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN REQUESTED THAT THE PRODUCT BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

    Description of Event or Problem · 1

    DRIED RESIDUE COATING ON SURFACE OF LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286563 DISPOSABLE VITRECTOMY LENS: FLAT VITRECTOMY CONTACT LENS, SINGLE-USE HJK D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA 2000386969 (2206157)

    Patients

    Seq Age Sex Outcome Treatment
    1