BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE VITRECTOMY LENS: FLAT

    MDR report key: 10535254 · Received September 15, 2020

    Report

    Report Number
    1222074-2020-00066
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
    Product Code
    HJK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WITH REGARD TO THIS COMPLAINT, 1 LENS WRAPPED IN A FOLDED PINK POST-IT INCLUDED IN A PLASTIC BAG WAS RECEIVED FOR INVESTIGATION. DUE TO THE PACKAGING METHOD VISUAL INSPECTION WAS HINDERED BY ADDITIONAL CONTAMINATION OF THE LENS DURING TRANSPORT. VISUAL INSPECTION CONFIRMED THE PRESENCE OF CRYSTALS ON THE LENS. 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. THE RESULTS OF THE FORENSIC INVESTIGATION OF THE PARTICULATE MATTER (IDENTIFIED ON THE LENS) BY SGS 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 THE INVESTIGATION PERFORMED AND TAKING INTO ACCOUNT THE NATURE OF THE SUBSTANCES IDENTIFIED, IT IS CONCLUDED THAT THE REPORTED EVENT IS CAUSED BY AN UNINTENDED USE ERROR, WHERE AFTER OPENING, THE LENSES WERE EXPOSED TO THE SUBSTANCES IDENTIFIED. THE RISK IDENTIFIED IS INCLUDED IN THE RISK MANAGEMENT DOCUMENTATION AND IS MITIGATED BY DESIGN AND MANUFACTURING PROCESS CONTROLS. TREND ANALYSIS INDICATES THAT THE PRODUCT IS PERFORMING WITHIN ANTICIPATED RATES. THEREFORE, NO REMEDIAL OR CORRECTIVE/PREVENTIVE ACTIONS WILL BE UNDERTAKEN AT THIS MOMENT. COMPLAINTS WILL BE CLOSELY MONITORED TO IDENTIFY ANY SIGNIFICANT ADVERSE TRENDS.

    Additional Manufacturer Narrative · 0

    WITH REGARDS TO THIS EVENT, 1 DISPOSABLE VITRECTOMY LENS WAS RECEIVED. THE DISPOSABLE LENS WAS PROVIDED WITHOUT ITS ORIGINAL PACKING. VISUAL INSPECTION CONFIRMED THE PRESENCE OF A FIBER-LIKE MATERIAL, DUST AND A WHITE DRY RESIDUE MATERIAL ON THE LENS. AS THE NATURE OF THE RESIDUE COULD NOT BE CLEARLY DETERMINED WITHIN D.O.R.C., THE LENS HAS BEEN SENT TO SGS LABORATORY IN BELGIUM FOR ANALYSIS. AS SOON AS THE ANALYSIS RESULTS ARE AVAILABLE, THE ROOT CAUSE INVESTIGATION WILL BE CONTINUED. NO CORRECTIVE/PREVENTIVE ACTIONS CAN BE IMPLEMENTED UNTIL THE INVESTIGATION HAS BEEN COMPLETED. THE LENS HAS BEEN SENT TO SGS LABORATORY IN BELGIUM FOR THE RESIDUE TO BE ANALYSED.

    Description of Event or Problem · 0

    THE LENS WAS DIRTY. THERE WERE WHITE DEPOSITS. THE NURSE INFORMED THE COMPANY THAT SHE HAD SEEN MANY INCIDENCES OF THIS IN RECENT DAYS.

    Description of Event or Problem · 0

    THE LENS WAS DIRTY. THERE WERE WHITE DEPOSITS. THE NURSE INFORMED THE COMPANY THAT SHE HAD SEEN MANY INCIDENCES OF THIS IN RECENT DAYS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE INCIDENT WILL BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE LENS WAS DIRTY. THERE WERE WHITE DEPOSITS. THE NURSE INFORMED THE COMPANY THAT SHE HAD SEEN MANY INCIDENCES OF THIS IN RECENT DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001352 DISPOSABLE VITRECTOMY LENS: FLAT VITRECTOMY CONTACT LENS, SINGLE-USE HJK D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. 2000413099 (2302215)

    Patients

    Seq Age Sex Outcome Treatment
    1