BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 24691563 · Received March 25, 2026

    Report

    Report Number
    3012236936-2026-000076
    Event Type
    Injury
    Date Received
    March 25, 2026
    Report Date
    March 25, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474810815
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B3: DATE OF EVENT: UNKNOWN/NOT PROVIDED. THE BEST ESTIMATE DATE IS BETWEEN OCT 6, 2025 TO MARCH 9, 2026. DEVICE EVALUATION: PRODUCT EVALUATION WAS NOT PERFORMED BECAUSE THE PRODUCT HAS NOT BEEN RECEIVED. THE COMPLAINT ISSUE REPORTED COULD NOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FOR THIS PO. CONCLUSION: BASED ON THE INVESTIGATION, NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, THE INFORMATION HAS NOT BEEN PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    PATIENT HAD CLEAR LENS EXCHANGE (CLE) IN LEFT EYE AND A JNJ TECNIS ODYSSEY IOL WAS IMPLANTED. PATIENT PRE-PHACO REFRACTION: OS +2.25 -0.50 X 135. POST TREATMENT PATIENT PRESENTED WITH PERSISTENT MULTIFOCAL DYSPHOTOPSIA SYMPTOMS (DAYTIME RINGS, HALOS, GLARE, AND OVERALL FILMY VISION). THE PATIENT FEELS UNABLE TO DRIVE DURING THE DAYTIME OR NIGHTTIME BECAUSE OF RINGS AND GLARE AROUND ALL LIGHT SOURCES. NO POSTERIOR CAPSULAR OPACIFICATION (PCO) WAS PRESENT. SYMPTOMS DID NOT IMPROVE WITH DRY EYE TREATMENT. ODYSSEY LENS WAS EXPLANTED AND REPLACED WITH A BAUSCH & LOMB LI61AO +21.5. DURING THE PROCEDURE, A TEMPORAL 10-0 NYLON SUTURE WAS PLACED AT THE MAIN INCISION. NO UNPLANNED SURGICAL INTERVENTIONS AND NO MEDICATIONS OUTSIDE THE STANDARD CARE WERE REQUIRED. NO PATIENT INJURIES OCCURRED DURING THE EXPLANTATION, AND THE PATIENT REPORTED RESOLUTION OF DYSPHOTOPSIA SYMPTOMS AND WAS DOING WELL IN THE LEFT EYE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755189 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474810815

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention