BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 18384340 · Received December 22, 2023

    Report

    Report Number
    3012236936-2023-03253
    Event Type
    Injury
    Date Received
    December 22, 2023
    Report Date
    January 29, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    POE
    UDI-DI
    05050474761629
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW, IT WAS NOTED THAT A DUPLICATE MDR REPORT (REPORT NUMBER WAS INADVERTENTLY SUBMITTED FOR THE SN 3027452213 WHILE THE EVENT HAD BEEN REPORTED EARLIER UNDER REPORT THE NUMBER 3012236936-2023-03152. THIS SUPPLEMENTAL MDR REPORT IS CORRECT THAT INFORMATION AND TO INDICATE THAT NO FURTHER INFORMATION WILL BE PROVIDED UNDER THIS MANUFACTURER REPORT NUMBER. ANY ADDITIONAL INFORMATION WILL BE REPORTED UNDER MANUFACTURER REPORT NUMBER 3012236936-2023-03152. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION B3: DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS BETWEEN JAN 24, 2023 AND NOV 13, 2023. SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H6 - MEDICAL DEVICE PROBLEM CODE: 3191 - TO CAPTURE DISSATISFACTION - QUALITY/DESIGN. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A MALE PATIENT REPORTED OF INTRAOCULAR LENS (IOL) EXPLANTS ON BOTH EYES (OU) DUE TO EXPERIENCING HALOS, GLARE AND PHYSICAL DISCOMFORT. PRIOR TO SURGERY, THE PATIENT HAD CATARACTS AND -600 VISION IN BOTH EYES. AFTER SURGERY THE PATIENT EXPERIENCED GLARES AND HALOS THAT IMPACTED HIS ABILITY TO DRIVE AND GO OUTSIDE. THE PATIENT STATED FOR NINE (9) MONTHS LIGHT MADE HIM CRY AND EVEN HAD TROUBLE WITH LIGHTS ON IN THE HOUSE. WHILE THE PATIENT HAD THE LENSES, HIS EYELIDS FELT LIKE MUSHY SPONGES AND WERE CONSTANTLY BLOODSHOT. THE PATIENT ATTRIBUTES THE ISSUE HE EXPERIENCED TO COATING AND THE DESIGN OF THE LENSES, COLLECTING TOO MUCH SUNLIGHT. THE PATIENT WAS TOLD HER WOULD SEE FROM "INFINITY TO 14 FEET" AND HE DID NOT WANT TO WEAR GLASSES ANYMORE AND TO BE ABLE TO READ THE PAPER. THE PATIENT SAW OTHER DOCTORS AND WAS ADVISED TO HAVE THEM REMOVED. THE LENSES WERE EXCHANGED, AND THE PATIENT HAS 20/20 VISION IN BOTH EYES WITH JOHNSON & JOHNSON MONOFOCAL REPLACEMENT LENSES. THE PATIENT STILL HAS TO WEAR GLASSES. A MONTH LATER 1.75 LEFT EYE, 2.0 RIGHT EYE. THE PATIENT IS DOING FINE WITH THE REPLACEMENT LENSES AND ONLY HAS SOME LEFTOVER CONDITIONS LIKE ITCHY EYES AND TEARS WHICH ARE DISSIPATING. HE WAS GIVEN DROPS ONLY FOR THE STANDARD POST-OP SURGERY AND AFTER THAT WAS TOLD TO USE OVER THE COUNTER (OTC) EYE DROPS. DURING EXPLANT PROCEDURES, THERE WERE NO OTHER INTERVENTIONS OR INJURIES. ONLY, WAS TOLD THAT THERE WAS A LITTLE TROUBLE EXPLANTING THE RIGHT EYE AS IT HAD HEALED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE ISSUES REPORTED WITH THE EXPLANTED LENS FOR THE PATIENT¿S RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE ISSUES WITH THE EXPLANTED LENS FOR THE PATIENT¿S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298934 TECNIS SIMPLICITY EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO PUERTO RICO MFG. INC. DXR00V 05050474761629

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention