BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE VITRECTOMY LENS: MAGNIFYING

    MDR report key: 10246421 · Received July 8, 2020

    Report

    Report Number
    1222074-2020-00047
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Manufacturer
    DUTCH OPHTHALMIC USA
    Product Code
    HJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ARTICLES WERE REQUESTED BY D.O.R.C. FOR INVESTIGATION. COMPLAINT ARTICLES, 5 DISPOSABLE VITRECTOMY LENSES ALL OF WITH THE SAME BATCH NUMBER, WERE RECEIVED. 3 DISPOSABLE LENSES WERE RECEIVED IN UNOPENED PACKING AND NO PRESENCE OF FOREIGN MATERIAL COULD BE OBSERVED ON THESE LENSES. 2 DISPOSABLE LENSES WERE PROVIDED IN OPEN BLISTERS. VISUAL INSPECTION CONFIRMED THE PRESENCE OF A WHITE DRY RESIDUE ON THE TWO LENSES. AS THE NATURE OF THE RESIDUE COULD NOT BE CLEARLY DETERMINED WITHIN D.O.R.C., THE LENSES WERE SENT TO SGS LABORATORY IN BELGIUM FOR ANALYSIS. AS SOON AS THE ANALYSIS RESULTS ARE AVAILABLE, THE ROOT CAUSE INVESTIGATION WILL BE CONTINUED. NO APPROPRIATE CORRECTIVE/PREVENTATIVE ACTIONS CAN BE TAKEN UNTIL THE INVESTIGATION IS COMPLETED. THE LENSES WERE SENT TO SGS LABORATORY IN BELGIUM FOR ANALYSIS. WITH REGARD TO THIS COMPLAINT, FIVE DISPOSABLE VITRECTOMY LENSES WERE RECEIVED FOR INVESTIGATION. THREE DISPOSABLE LENSES WERE RECEIVED IN UNOPENED PACKING AND VISUAL INSPECTION COULD NOT REVEAL ANY PRESENCE OF FOREIGN MATERIAL. TWO OF THE LENSES WERE RECEIVED IN OPEN BLISTERS AND VISUAL INSPECTION OF THESE TWO LENSES, CONFIRMED THE PRESENCE OF A WHITE DRY RESIDUE ON BOTH LENSES. BATCH RECORD REVIEW INDICATED THAT NO ABNORMALITIES WITH REGARD TO DIRT, DEBRIS, OR FOREIGN MATERIAL WERE IDENTIFIED DURING THE IN-PROCESS VISUAL INSPECTION STEP. AS THE NATURE OF THE MATERIAL COULD NOT BE CLEARLY DETERMINED WITHIN D.O.R.C., THE LENSES WERE SENT TO SGS LABORATORY IN BELGIUM FOR FORENSIC ANALYSIS. RESULTS OF THE INVESTIGATION OF THE PARTICULATE MATTER (IDENTIFIED ON THE LENSES) REVEALED THE PRESENCE OF SODIUM HYALURONATE, SODIUM, CHLORINE, POTASSIUM AND CALCIUM. 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.

    Additional Manufacturer Narrative · 0

    COMPLAINT ARTICLES WERE REQUESTED BY D.O.R.C. FOR INVESTIGATION. COMPLAINT ARTICLES, 5 DISPOSABLE VITRECTOMY LENSES ALL OF WITH THE SAME BATCH NUMBER, WERE RECEIVED. 3 DISPOSABLE LENSES WERE RECEIVED IN UNOPENED PACKING AND NO PRESENCE OF FOREIGN MATERIAL COULD BE OBSERVED ON THESE LENSES. 2 DISPOSABLE LENSES WERE PROVIDED IN OPEN BLISTERS. VISUAL INSPECTION CONFIRMED THE PRESENCE OF A WHITE DRY RESIDUE ON THE TWO LENSES. AS THE NATURE OF THE RESIDUE COULD NOT BE CLEARLY DETERMINED WITHIN D.O.R.C., THE LENSES WERE SENT TO SGS LABORATORY IN BELGIUM FOR ANALYSIS. AS SOON AS THE ANALYSIS RESULTS ARE AVAILABLE, THE ROOT CAUSE INVESTIGATION WILL BE CONTINUED. NO APPROPRIATE CORRECTIVE/PREVENTATIVE ACTIONS CAN BE TAKEN UNTIL THE INVESTIGATION IS COMPLETED. THE LENSES WERE SENT TO SGS LABORATORY IN BELGIUM FOR ANALYSIS.

    Description of Event or Problem · 0

    DURING A PROCEDURE, AFTER THE SURGEON PLACED THE MAGNIFYING LENS ON THE EYE, HE NOTICED THAT THERE IS A FILM ON A SURFACE OF THE LENS, WHICH OBSTRUCTED HIS VISION. THE NEXT LENS OPENED (WITH THE SAME LOT NUMBER) WAS ALSO COVERED WITH THE FILM. THE SURGERY WAS COMPLETED WITH A LENS FROM ANOTHER LOT. PATIENT HARM DID NOT OCCUR.

    Description of Event or Problem · 0

    DURING A PROCEDURE, AFTER THE SURGEON PLACED THE MAGNIFYING LENS ON THE EYE, HE NOTICED THAT THERE IS A FILM ON A SURFACE OF THE LENS, WHICH OBSTRUCTED HIS VISION. THE NEXT LENS OPENED (WITH THE SAME LOT NUMBER) WAS ALSO COVERED WITH THE FILM. THE SURGERY WAS COMPLETED WITH A LENS FROM ANOTHER LOT. PATIENT HARM DID NOT OCCUR.

    Additional Manufacturer Narrative · 1

    COMPLAINT ARTICLES WERE REQUESTED BY D.O.R.C. FOR INVESTIGATION.

    Description of Event or Problem · 1

    DURING A PROCEDURE, AFTER THE SURGEON PLACED THE MAGNIFYING LENS ON THE EYE, HE NOTICED THAT THERE IS A FILM ON A SURFACE OF THE LENS, WHICH OBSTRUCTED HIS VISION. THE NEXT LENS OPENED (WITH THE SAME LOT NUMBER) WAS ALSO COVERED WITH THE FILM. THE SURGERY WAS COMPLETED WITH A LENS FROM ANOTHER LOT. PATIENT HARM DID NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712657 DISPOSABLE VITRECTOMY LENS: MAGNIFYING VITRECTOMY CONTACT LENS, SINGLE-USE HJK DUTCH OPHTHALMIC USA 2000407686

    Patients

    Seq Age Sex Outcome Treatment
    1