BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 21186373 · Received January 18, 2025

    Report

    Report Number
    3012236936-2025-000016
    Event Type
    Malfunction
    Date Received
    January 18, 2025
    Date of Event
    January 7, 2025
    Report Date
    May 29, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474746640
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION. SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES SECTION D9: DATE RETURNED TO MANUFACTURER: APR 18, 2025 SECTION H3: EVALUATED BY MANUFACTURER: YES DEVICE EVALUATION: THE PRELOADED DEVICE WAS RECEIVED. THE PRODUCT WAS VISUALLY INSPECTED UNDER MAGNIFICATION REVEALING NO DAMAGE TO THE CARTRIDGE OR HANDPIECE. DURING THE INSPECTION OF THE PLUNGER ROD DAMAGE WAS OBSERVED AND A GROOVE WAS NOTICED WITH MISSING PLUNGER ROD MATERIAL. A PARTICLE WAS RECEIVED INSIDE A SPECIMEN CUP THAT MATCHED THE MISSING PIECE OF PLUNGER ROD. THE PARTICLE WAS FORWARDED TO THE EAG LAB FOR FTIR (FOURIER TRANSFORM INFRARED SPECTROSCOPY), ANALYSIS. PER EAG LABORATORIES, THE MATERIAL IS CONSISTENT WITH A MIXTURE OF A PHTHALATE PLASTICIZER, PVC, AND SODIUM HYALURONATE. THE FTIR SPECTRUM RAW DATA OUTPUT FILE GENERATED BY EAG LABORATORIES WAS COMPARED AGAINST THE MANUFACTURING PROCESS FTIR LIBRARY AND DID NOT YIELD ANY RESULTS WITH AT LEAST A 0.90000 CORRELATION. THE CUSTOMER PROVIDED PHOTO WAS EVALUATED. THE PHOTO DISPLAYS THE SUSPECT LENS INSIDE THE PATIENT'S EYE AND AN UNKNOWN MATERIAL CAN BE OBSERVED NEAR THE CENTER OF THE LENS. THE IOL WAS NOT RECEIVED. NO FURTHER EVALUATION COULD BE PERFORMED. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A3B, GENDER: UNKNOWN/NOT PROVIDED. SECTION A4, PATIENT WEIGHT: UNKNOWN/NOT PROVIDED. SECTION A5, ETHNICITY: UNKNOWN/NOT PROVIDED. SECTION A6, RACE: 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, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE 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

    DEVICE EVALUATION: THE CUSTOMER PROVIDED PHOTO WAS EVALUATED. THE PHOTO DISPLAYS THE SUSPECT LENS INSIDE THE PATIENT'S EYE AND AN UNKNOWN MATERIAL CAN BE OBSERVED NEAR THE CENTER OF THE LENS. DUE TO NO PRODUCT RECEIVED, NO FURTHER EVALUATION COULD BE PERFORMED. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD A FOREIGN MATERIAL. A PLASTIC PIECE CAME OUT OF THE SIMPLICITY INJECTOR. THE ISSUE WAS NOTICED AFTER THE LENS WAS IMPLANTED INTO THE EYE. REPORTEDLY, THE DIRECTIONS FOR USE WERE FOLLOWED. THE IOL WAS REMOVED AND REPLACED WITH THE SAME MODEL AND DIOPTER HENCE THERE WAS SOME DELAY IN THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED SUCH AS AN INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS REQUIRED. THE PATIENT¿S DAILY ACTIVITIES WERE NOT IMPACTED BY THIS EVENT. AND THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006108 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU150 05050474746640

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female