BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 22720575 · Received August 5, 2025

    Report

    Report Number
    3012236936-2025-000212
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    June 5, 2025
    Report Date
    November 7, 2025
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474810747
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4, A5, A6, PATIENT INFORMATION: UNKNOWN/NOT PROVIDED. SECTION D6A, IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. THEREFORE, NOT EXPLANTED. SECTION H3, DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: BASED ON THE NEW INFORMATION RECEIVED, IT WAS LEARNED THAT THE EVENT FOR SERIAL NUMBER (B)(6) WAS ALREADY CAPTURED AND SUBMITTED UNDER THE MANUFACTURER REPORT NUMBER 3012236936-2025-0001811. AT THE TIME OF THE SUBMISSION THE SERIAL NUMBER WAS UNKNOWN BUT WAS SUBSEQUENTLY RECEIVED VIA THIS NEW INFORMATION. NO FURTHER INFORMATION WILL BE PROVIDED UNDER THIS MANUFACTURER REPORT NUMBER 3012236936-2025-0002122, AS IT HAS NOW BEEN DETERMINED TO BE A DUPLICATE REPORT. ADDITIONAL INFORMATION: THE DOCTOR¿S FIRST NAME WAS PROVIDED AS (B)(6). DOCTOR¿S EMAIL WAS UPDATED TO (B)(6) AND THEIR TELEPHONE NUMBER IS (B)(6). THE PATIENT¿S OUTCOME WAS REPORTED AS "GOOD". THERE WAS NO PATIENT INJURY OR COMPLICATIONS AND NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR RETURN (DISCARDED). THE NEW INFORMATION ALSO CLARIFIED THAT THE IOL TOUCHED THE EYE BUT DID NOT DEPLOY BECAUSE IT WAS STUCK INSIDE THE CARTRIDGE. SECTION E1, FIRST/GIVEN NAME: (B)(6). SECTION E1, EMAIL ADDRESS: (B)(6). SECTION E1, TELEPHONE NUMBER: (B)(6). SECTION H6, HEALTH EFFECT - IMPACT CODE: 2199 IS BEING USED TO REPORT NO HEALTH CONSEQUENCES DUE TO THE NEW INFORMATION RECEIVED THE IOL TOUCHED THE EYE BUT DID NOT DEPLOY, WAS NOT INSERTED INTO THE EYE. SECTION H6, DEVICE CODE(S): 2983 MECHANICAL JAM. SECTION H6, TYPE OF INVESTIGATION 4115 DEVICE DISCARDED. MOVING FORWARD ANY NEW INFORMATION RECEIVED WILL BE REPORTED UNDER MANUFACTURER REPORT NUMBER 3012236936-2025-0001811. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER IMPLANTING THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) INTO THE PATIENT'S LEFT EYE IT WAS FOUND TO BE DEFECTIVE. THE IOL WAS IMMEDIATELY REMOVED AND REPLACED WITH A NEW LENS OF THE SAME MODEL DRN00V 19.0 DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS A VITRECTOMY, INCISION ENLARGEMENT OR SUTURES. THE PATIENT¿S OUTCOME WAS REPORTED AS STABLE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2684393 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474810747

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male