BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 23999100 · Received January 7, 2026

    Report

    Report Number
    3012236936-2026-000012
    Event Type
    Injury
    Date Received
    January 7, 2026
    Date of Event
    August 8, 2025
    Report Date
    February 21, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474810594
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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: JAN 12, 2026. SECTION H3: EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED. THE LENS WAS VISUALLY INSPECTED REVEALING THAT THE LENS WAS COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED AND INSPECTED AND NO ISSUES WERE IDENTIFIED. DURING THE PRODUCT EVALUATION IT WAS CONFIRMED THAT THE PHYSICAL CHARACTERISTICS OF THE LENS MATCHED A DRN00V MODEL LENS. 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 A4, PATIENT WEIGHT: UNKNOWN/NOT PROVIDED. SECTION A5, ETHNICITY: UNKNOWN/NOT PROVIDED. SECTION A6, RACE: UNKNOWN/NOT PROVIDED. 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 AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPT WAS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE. DURING A POST-OPERATIVE EXAMINATION, THE PATIENT REPORTED VISUAL DISTURBANCES, INCLUDING SHADOWS OR "AURAS" AROUND LETTERS AND WORDS, UNCLEAR DISTANCE AND NEAR VISION, DIFFICULTY READING, HALOS AROUND LIGHTS, AND GLARE. THE PATIENT¿S PRE-OPERATIVE VISION WAS RECORDED AS 20/50 - 2, WHILE POST-OPERATIVE VISION WAS NOTED AS 20/30. MEDICAL ATTENTION WAS SOUGHT, AND PREDNISOLONE ACETATE WAS PRESCRIBED. THE IOL WAS SUBSEQUENTLY EXPLANTED. THERE WERE NO SUTURES OR VITRECTOMY REQUIRED. NO FURTHER INFORMATION IS AVAILABLE REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60681 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474810594

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention