BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 22102352 · Received May 28, 2025

    Report

    Report Number
    3012236936-2025-000151
    Event Type
    Injury
    Date Received
    May 28, 2025
    Report Date
    June 16, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    POE
    UDI-DI
    05050474761803
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT 3012236936-2025-0001519 SHOULD HAVE INCLUDED THE FOLLOWING INFORMATION. THIS CURRENT REPORT PROVIDES THE CORRECTION BELOW. SECTION H6, HEALTH EFFECT - IMPACT CODE: 4625 - ADDITIONAL SURGERY, IS BEING USED TO CAPTURE THE SECONDARY SURGICAL INTERVENTION TO REPOSITION THE IOL INSIDE THE PATIENT'S EYE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A3B, GENDER: "MALE". SECTION B3, DATE OF EVENT: THE EXACT DATE IS UNKNOWN. THE BEST ESTIMATE IS DURING A POST-OPERATIVE VISIT APPROXIMATELY ONE WEEK AFTER THE IMPLANT. SECTION D6A, IF IMPLANTED, GIVE DATE: THE BEST ESTIMATE IS AROUND (B)(6) 2024. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS IT REMAINS IMPLANTED. 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. AN ATTEMPT WAS MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, IT WAS NOT PROVIDED. 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 AROUND (B)(6) 2024. THE PATIENT SAID HIS WHOLE GOAL WAS TO BE ABLE TO READ WITHOUT GLASSES. INSTEAD, HE STILL HAS MANY GLASSES THAT HE USES TO READ. THE PATIENT SAID THAT HE MAY NOT HAVE TOLD HIS DOCTOR THAT HIS GOAL WAS TO BE ABLE TO READ WITHOUT GLASSES. THE PATIENT EXPERIENCED BLURRED VISION IN HIS RIGHT EYE WHICH HIS DOCTOR ATTRIBUTES TO HIS MACULAR DEGENERATION. THE DOCTOR EXPLAINED TO THE PATIENT THAT HIS MACULAR DEGENERATION IS NOT DUE TO THE IOL. THE ISSUE WAS FIRST NOTICED DURING A POST-OPERATIVE VISIT APPROXIMATELY ONE WEEK AFTER THE IMPLANT. INITIALLY, THE DOCTOR HAD SCHEDULED AN EXPLANT BUT WAS SUBSEQUENTLY CANCELLED. HIS DOCTOR SAID THE IOL MOVED AND IN (B)(6) 2024 THE LENS WAS REPOSITIONED. THE PATIENT SAID HE WILL SEEK A SECOND OPINION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822095 TECNIS SIMPLICITY EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO PUERTO RICO MFG. INC. DXR00V 05050474761803

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention