BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 15841707 · Received November 22, 2022

    Report

    Report Number
    3012236936-2022-02873
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Date of Event
    October 27, 2022
    Report Date
    November 22, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474542068
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY EXPLANT DATE: NOT APPLICABLE, AS LENS WAS NOT EXPLANTED. ESTABLISHMENT NAME: UNKNOWN/NOT PROVIDED. ADDRESS: UNKNOWN/NOT PROVIDED. TELEPHONE NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED (THE LENS REMAINS IMPLANTED). THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: BASED ON THE MANUFACTURING RECORDS REVIEW, AND HISTORICAL COMPLAINT REVIEW, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. NO NONCONFORMITY REPORT, DOCUMENTATION OR LABELING CHANGES, AND ESCALATIONS ARE REQUIRED. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FOR THIS PO. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CLINICAL STUDY SIX MONTHS POST-OP VISIT, IT WAS OBSERVED THAT THE INTRAOCULAR LENS (IOL) IMPLANTED IN THE PATIENT'S RIGHT EYE WAS DISLOCATED-ROTATED 11 DEGREES. THE PATIENT IS NOTED TO BE TEMPORARILY IMPAIRED. NO INTERVENTION PERFORMED. IOL REMAINS IMPLANTED. PRE-OP COMMENTS: 0.63 AND POST-OP COMMENTS: 0.80. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2733557 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZMT150 05050474542068

    Patients

    Seq Age Sex Outcome Treatment
    1 Female