BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 21988420 · Received May 8, 2025

    Report

    Report Number
    3012236936-2025-000117
    Event Type
    Injury
    Date Received
    May 8, 2025
    Report Date
    May 8, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, 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 B3: DATE OF EVENT: EXACT DATE NOT PROVIDED. ARTICLE ACCEPTANCE DATE: NOV 13, 2023. SECTION D4: MODEL NUMBER AND CATALOG NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IT WAS INDICATED THAT 422 EYES WERE IMPLANTED WITH A TECNIS ENHANCE INTRAOCULAR LENS (IOL). . SECTION D6B - EXPLANT DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS EXPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. NO SERIAL NUMBER WAS PROVIDED FOR THIS DEVICE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: SHALINI BANERJEE, CLAUDE KAUFMANN, CHIARA TINNER, KATJA ISELIN, CHRISTOPH ANDREAS AMSTUTZ, YING-YU MELODY HEDINGER, MARTIN K. SCHMID, MICHAEL THIEL ; KLIN MONATSBL AUGENHEILKD 2024; 241: PP. 369¿373 THIEME ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: PATIENT-REPORTED OUTCOME MEASURES (PROMS) WITH REFRACTIVE AND DIFFRACTIVE EXTENDED DEPTH OF FOCUS (EDOF) INTRAOCULAR LENSES A PROSPECTIVE OBSERVATIONAL STUDY WAS DONE TO ASSESS SPECTACLE INDEPENDENCE FOR FAR-RANGE, MID-RANGE, AND NEAR-VISION ACTIVITIES IN PATIENTS AFTER IMPLANTATION OF REFRACTIVE OR DIFFRACTIVE EDOF-IOLS USING PATIENT-REPORTED OUTCOME MEASURES (PROMS) IN A REAL-WORLD SETTING. A TOTAL OF 514 PATIENTS UNDERWENT BILATERAL CATARACT SURGERY AND WERE IMPLANTED WITH EITHER A DIFFRACTIVE EDOF-IOL AT LARA (N=92 PATIENTS) (CARL ZEISS MEDITEC AG) OR A REFRACTIVE EDOF-IOL TECNIS ENHANCE (N=422 EYES) (JOHNSON & JOHNSON VISION INC.). IT WAS REPORTED THAT 54% OF THE PATIENTS WITH TECNIS ENHANCE REPORTED WEARING GLASSES RARELY, 15% REPORTED USING GLASSES SOMETIMES, 8% REPORTED NEEDING SPECTACLES FREQUENTLY, AND 14% REPORTED NEEDING SPECTACLES CONSTANTLY. IT WAS REPORTED THAT 15% OF THE PATIENTS WITH TECNIS ENHANCE REPORTED TO OCCASIONALLY PERCEIVE SOME LIGHT PHENOMENA (GLARE AND HALOS). IT WAS REPORTED THAT 1% OF THE PATIENTS WITH TECNIS ENHANCE REPORTED THAT THEY WERE LESS SATISFIED. POTENTIAL COMPLAINTS: YES SERIOUS INJURY: YES ALL PATIENTS UNDERGOING BILATERAL CATARACT SURGERY AT THE DEPARTMENT OF OPHTHALMOLOGY, LUCERNE CANTONAL HOSPITAL IN 2021 AND 2022 AND IMPLANTED WITH AN EDOF-IOL AIMING FOR BILATERAL EMMETROPIA WERE INCLUDED IN THE STUDY. EXCLUSION CRITERIA WERE PREEXISTING OCULAR COMORBIDITIES WITH REDUCED VISUAL POTENTIAL, OR UNWILLINGNESS OR INABILITY TO REPORT THEIR OUTCOME. PATIENTS WERE ASSIGNED TO EXPERIENCED EYE SURGEONS IMPLANTING EITHER REFRACTIVE (FOUR SURGEONS) OR DIFFRACTIVE (THREE SURGEONS)EDOF-IOLS. IT IS UNKNOWN IF THE DEVICES USED IN SWITZERLAND ARE CARL ZEISS OR JOHNSON & JOHNSON PRODUCTS. A COPY OF THE ARTICLE IS ATTACHED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021641 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention