BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS TORIC

    MDR report key: 23612305 · Received November 20, 2025

    Report

    Report Number
    3012236936-2025-000299
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    December 21, 2023
    Report Date
    November 20, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4, PATIENT WEIGHT: UNKNOWN/NOT PROVIDED. SECTION A6, RACE: ¿CAUCASIAN¿ . SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THERE IS NO INDICATION THE IOL WAS EXPLANTED. SECTION H3, DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. H4 DEVICE MANUFACTURE DATE: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. AN ATTEMPT WAS MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, IT WAS REPORTED THAT NO MORE INFORMATION IS AVAILABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    RACE= CAUCASIAN. OTHER= NOT HISPANIC/LATINO. IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2023 INTO THE PATIENT¿S RIGHT EYE. THE PATIENT WAS PART OF A RETROSPECTIVE CLINICAL STUDY. THE LENS POWER IS A +22.0 DIOPTER. ON THE PATIENT¿S 1-DAY POSTOPERATIVE VISIT (B)(6)2023 THEY HAD CORNEAL EDEMA IN THEIR RIGHT EYE. THEIR INTRAOCULAR PRESSURE (RIGHT EYE) WAS 18 MM HG WHICH IS 3 MM HG CHANGE FROM BASELINE. THE PATIENT¿S SNELLEN UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) RESULTS ARE 20/40. THE TECNIS TORIC CALCULATOR WAS NOT USED IN THIS LENS SELECTION. ALCON CENTURION WAS THE PHACOEMULSIFICATION SYSTEM USED AND LENSX WAS THE LASER SYSTEM. THE LENS INSERTION SYSTEM USED IS A PLATINUM 1MTEC30 CARTRIDGE AND THE D&K HANDPIECE. 500 ML OF BALANCED SALT SOLUTION (BSS) WAS USED. THERE WERE NO SURGICAL COMPLICATIONS AND NO ADDITIONAL PROCEDURES APPLIED. THE PATIENT'S RELEVANT OCULAR HISTORY AND MEDICATION ARE EPIRETINAL MEMBRANE RIGHT EYE, POSTERIOR VITREOUS DETACHMENT BOTH EYES. THE MEDICATION IS LUMIFY ONCE A DAY IN BOTH EYES (QD OU). THESE SYMPTOMS CONTINUED AFTER THE IOL WAS IMPLANTED. THE FOLLOWING ARE THE PATIENT¿S OCULAR-RELATED/MEDICAL FINDINGS FOR THEIR RIGHT EYE IN THEIR POST OPERATIVE VISITS. THE VISITS ARE LISTED BELOW. DERMATOCHALASIS, CORNEAL EDEMA, DRY EYE/SUPERFICIAL PUNCTATE KERATOPATHY/PUNCTATE EPITHELIAL EROSION/TEAR FILM INSUFFICIENCY, POSTERIOR VITREOUS DETACHMENT (PRE-EXISTING CONDITION) AND/OR FLOATERS, EPIRETINAL MEMBRANE (PRE-EXISTING CONDITION). IN THE PATIENT¿S FORM FOR (B)6)2025 POST-OPERATIVE VISIT CORNEAL EDEMA WAS MARKED FALSE. HOWEVER, IT WAS REPORTED THAT OVERALL THERE WAS TRACE OF CORNEAL EDEMA STILL NOTED AT THE EXIT OF THE STUDY. FOLLOW-UP VISITS. (B)(6) 2024, THE PATIENT¿S RIGHT EYE INTRAOCULAR PRESSURE WAS 13 MM HG. REDUCTION OF -2 MM HG. UCDVA 20/25. BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) 20/20. (B)(6) 2024, THE PATIENT¿S RIGHT EYE INTRAOCULAR PRESSURE WAS 14 MM HG. REDUCTION OF -1 MM HG. THE PATIENT¿S (BCDVA) WAS NOT MEASURED BECAUSE THEY DECLINED REFRACTION. IN FOLLOW-UP VISIT (B)(6) 2024, THE PATIENT¿S RIGHT EYE INTRAOCULAR PRESSURE WAS 11 MM HG. REDUCTION OF -4 MM HG. THE PATIENT¿S SPHERE FOR THEIR RIGHT EYE WAS REPORTED AS -00.75, CYLINDER -0.75, AXIS 007. UCDVA 20/40. BCDVA 20/25. IN SUMMARY, THE SEVERITY OF THE EVENT IS CLASSIFIED AS ¿MILD¿ AND IS NOT SERIOUS OR SIGHT THREATENING. REPORTEDLY, IT¿S UNLIKELY THE EVENT IS RELATED TO ANY JOHNSON AND JOHNSON PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2441624 TECNIS TORIC INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Other 1MTEC30 CARTRIDGE/D&K HANDPIECE