BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE VITRECTOMY LENS: WIDE VIEW

    MDR report key: 9181458 · Received October 11, 2019

    Report

    Report Number
    1222074-2019-00032
    Event Type
    Malfunction
    Date Received
    October 11, 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

    AN INVESTIGATION WILL BE INITIATED AS SOON AS THE COMPLAINT ARTICLES ARE RECEIVED BY D.O.R.C.. COMPLAINT ARTICLES, TWO DISPOSABLE VITRECTOMY LENSES IN SEPARATE CONTAINERS, WERE RECEIVED. A CLOUDY DRY RESIDUE WAS IDENTIFIED IN A VISUAL INSPECTION. IN ORDER TO EXCLUDE THE MANUFACTURING PROCESS AS A POTENTIAL SOURCE OF CONTAMINATION, ADDITIONAL INFORMATION WAS REQUESTED FROM THE MANUFACTURING SITE (A SUBSIDIARY OF D.O.R.C.), WHERE LENSES ARE PACKED. IT WAS CONFIRMED BY THE MANUFACTURING SITE THAT 100% VISUAL INSPECTION OF THE LENSES IS IN PLACE (AND HAS ALWAYS BEEN EXECUTED) AT THE POINT OF PACKAGING AND BATCH RECORDED REVIEW INDICATED THAT DURING THE VISUAL INSPECTION NO ABNORMALITIES WITH REGARD TO DIRT, DEBRIS, OR FOREIGN MATERIAL WERE IDENTIFIED. AS THE ORIGIN OF THE RESIDUE COULD NOT BE CLEARLY DETERMINED WITHIN D.O.R.C., WE SENT THE LENSES TO SGS LABORATORY IN BELGIUM FOR ANALYSIS. AS SOON AS RESULTS ARE AVAILABLE, THE ROOT CAUSE INVESTIGATION WILL BE CONTINUED. - ATTACHMENT: [MIR 2019-001022 FOLLOW UP REPORT SIGNED.PDF]

    Additional Manufacturer Narrative · 0

    COMPLAINT ARTICLES, TWO DISPOSABLE VITRECTOMY LENSES IN SEPARATE CONTAINERS, WERE RECEIVED. A CLOUDY DRY RESIDUE WAS IDENTIFIED IN A VISUAL INSPECTION. BATCH RECORDED REVIEW INDICATED THAT DURING THE VISUAL INSPECTION NO ABNORMALITIES WITH REGARD TO DIRT, DEBRIS, OR FOREIGN MATERIAL WERE IDENTIFIED. AS THE ORIGIN OF THE RESIDUE COULD NOT BE CLEARLY DETERMINED WITHIN D.O.R.C., THE LENSES WERE SENT TO SGS LABORATORY IN BELGIUM FOR ANALYSIS. RESULTS OF THE INVESTIGATION OF THE PARTICULATE MATTER (IDENTIFIED ON THE LENSES) REVEALED THE PRESENCE OF THE FOLLOWING SUBSTANCES: SODIUM HYALURONATE, CALCIUM CITRATE. HOWEVER, THESE SUBSTANCES ARE NOT USED DURING THE MANUFACTURING OR PACKAGING PROCESS OF THE LENSES. FURTHERMORE, GLOVES ARE WORN DURING HANDLING OF THE VITRECTOMY LENSES IN BOTH THE MANUFACTURING AND PACKAGING PROCESS . BASED UPON THIS INFORMATION AND TAKEN INTO ACCOUNT THE NATURE OF THE SUBSTANCES IDENTIFIED IT IS MOST LIKELY THAT THE EVENT IS CAUSED BY AN UNINTENDED USE ERROR WHERE AFTER OPENING THE LENSES WERE EXPOSED TO THE SUBSTANCES IDENTIFIED.

    Description of Event or Problem · 0

    LENSE WAS DIRTY.

    Description of Event or Problem · 0

    LENSE WAS DIRTY.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WILL BE INITIATED AS SOON AS THE COMPLAINT ARTICLES ARE RECEIVED BY D.O.R.C.

    Description of Event or Problem · 1

    LENSE WAS DIRTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977159 DISPOSABLE VITRECTOMY LENS: WIDE VIEW VITRECTOMY CONTACT LENS, SINGLE-USE HJK D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA 2000405159

    Patients

    Seq Age Sex Outcome Treatment
    1