BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 21875766 · Received April 21, 2025

    Report

    Report Number
    3012236936-2025-000095
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Report Date
    September 3, 2025
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474709768
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6B: EXPLANT DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED, THEREFORE NOT EXPLANTED SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H6: HEALTH EFFECT - MEDICAL DEVICE PROBLEM CODE: 3191: LATHE LINES. SECTION H3: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION; HOWEVER, PHOTOGRAPHS AND A VIDEO PROVIDED BY THE CUSTOMER WERE EVALUATED. THE VIDEO AND IMAGES SHOW A PSEUDOPHAKIC EYE OBSERVED IN THE SLIT LAMP AND CLAIMED TO BE IMPLANTED WITH A TECNIS SYNERGY OPTIBLUE IOL PRELOADED IN THE SIMPLICITY DELIVERY SYSTEM, MODEL DFR00V. A CLOUDINESS/ GRAYISH DISCOLORATION WAS OBSERVED IN THE LENS CENTRAL RING. THE CLINICAL IMPACT OF THE REPORTED ISSUE AS WELL AS ITS POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED FROM A VIDEO/PICTURE EVALUATION. THE COMPLAINT ISSUE "LATHE LINES" WAS NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THEREFORE, THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE IS AN ISSUE WITH THE PRELOADED EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS (IOL), IMPLANTED IN THE LEFT EYE (OS), AS PART OF A BILATERAL IMPLANTATION ON (B)(6) 2024. THE SURGEON REPORTED THE PATIENT IS EXPERIENCING AN IRREGULARITY ON THE IOL, IN THE CENTRAL RING THAT IS BLURRY AS WELL AS AROUND THE FIRST RING. ACCORDING TO THE SURGEON, IT LOOKS LIKE THERE IS A POLISHING DEFECT. THE RIGHT EYE (OD) APPEARS NORMAL. THE PATIENT STATES SHE WAS PREVIOUSLY NEARSIGHTED AND PRESBYOPIC. SINCE THE SURGERY, SHE HAS NOTICED THAT HER OS FEELS DIFFERENT FROM HER OD. SHE EXPERIENCES SOME PERIPHERAL VISION BEING SLIGHTLY ¿OUT OF FOCUS,¿ OR AS IF THE LENS IS SLIGHTLY MISALIGNED. THIS IS MOST NOTICEABLE IN ENVIRONMENTS WITH MULTIPLE LIGHTS IN THE DARK OR UNDER FLUORESCENT LIGHTING, ESPECIALLY WHEN LOOKING AT A DISTANCE. SHE SAYS SHE IS NOT REFERRING TO HALOS, WHICH SHE HAS IN BOTH EYES, THIS IS SOMETHING ELSE. SHE INFORMS US SHE DEVELOPED POSTERIOR CAPSULE OPACIFICATION (PCO), WHICH WAS TREATED WITH LASER, BUT SHE STILL EXPERIENCES OCCASIONAL BLURRY VISION. IT COMES AND GOES, MOST OFTEN IN THE MORNING WHEN SHE WAKES UP. NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW UP WE LEARNED HALOS WERE REPORTED POST SURGERY ON (B)(6) 2024, THEY WERE NOT AN ISSUE BEFOREHAND. MILD PCO WAS DETECTED ON (B)(6) 2025, BECAUSE OF PATIENT SYMPTOMS. TREATMENT WITH YAG CAPSULOTOMY WAS DONE ON (B)(6) 2025 WITH ELEX YAG LASER, BOTH EYES TREATED ON THE SAME DAY, NO COMPLICATIONS DURING TREATMENT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE LEFT EYE(OS). A SEPARATE REPORT IS BEING SUBMITTED FOR THE RIGHT EYE (OD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518587 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DFR00V 05050474709768

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female