BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFORM CAPSULAR TENSION RING

    MDR report key: 19792594 · Received July 22, 2024

    Report

    Report Number
    1610287-2024-00034
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    February 20, 2024
    Report Date
    September 10, 2024
    Manufacturer
    MORCHER STUTTGART GMBH
    Product Code
    MRJ
    PMA / PMN Number
    P010059
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED NO IRREGULARITIES OR DEVIATIONS IN RELATION TO THE COMPLAINT. THE REVIEW CONFIRMS THAT THE PRODUCTION OF THE AFFECTED PRODUCT WAS IN ACCORDANCE WITH THE QUALITY MANAGEMENT SYSTEM AND APPLICABLE PROCEDURES. THE RECORDS CONFIRM COMPLIANCE WITH PRODUCT SPECIFICATIONS AND PRODUCT CONFORMITY. A PRODUCT EXAMINATION COULD NOT BE MADE DUE TO THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER. AN ANALYSIS OF THE HISTORICAL COMPLAINTS DATA IDENTIFIED TWO ADDITIONAL COMPLAINTS ORIGINATING FROM THE SAME FACILITY, ALONG WITH ONE COMPLAINT FROM THE SAME USER. HYGIENIC CONDITION OF THE PRODUCT, UNKNOWN, THE PRODUCT WAS NOT RETURNED. BASED ON THE INVESTIGATION RESULTS USER-RELATED FACTORS SUCH AS A CARELESSLY OR IMPROPER HANDLING AND LOADING TECHNIQUES MIGHT HAVE CAUSED THE COMPLAINT THE CAUSE MIGHT BE LINKED TO THE USER. TO ENSURE AN ADEQUATE INVESTIGATION, WE RECOMMEND THE RETURN OF CLAIMED PRODUCT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FOLLOWING INSERTION OF CAPSULAR TENSION RING (CTR) INTO CAPSULAR BAG SURGEON NOTICED THAT THE CTR WAS BENT OUT OF SHAPE UNUSUALLY. THE CTR WAS EXCHANGED FOR ANOTHER CTR MODEL FOLLOWING THE INITIAL PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ADVERSE EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING SURGERY WAS COMPLETED AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1978830 REFORM CAPSULAR TENSION RING RING, ENDOCAPSULAR MRJ MORCHER STUTTGART GMBH ACTR11 CCKCBN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown