BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 20720783 · Received November 19, 2024

    Report

    Report Number
    3012236936-2024-000306
    Event Type
    Injury
    Date Received
    November 19, 2024
    Report Date
    December 3, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474750661
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH FOLLOW-UP THE CUSTOMER PROVIDED THE DATE OF THE VITRECTOMY FOR HER RIGHT EYE. THIS CURRENT REPORT IS TO PROVIDE THIS INFORMATION. THE VITRECTOMY IN HER RIGHT EYE WAS DONE (B)(6) 2024. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION B3, DATE OF EVENT: THE EXACT DATE IS UNKNOWN. THE PATIENT SAID ¿RIGHT AFTER THE PROCEDURE¿. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE IOL HAS NOT BEEN EXPLANTED. SECTION H6- HEALTH EFFECT - IMPACT CODE: 4625 USED TO CAPTURE THE UNPLANNED VITRECTOMY AND THE YAG (YTTRIUM-ALUMINUM GARNET LASER TREATMENT) PROCEDURE. 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, 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, IT WAS NOT AVAILABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS DETERMINED THAT A CORRECTION FOR FOLLOW-UP#1 IS REQUIRED AS THE FOLLOWING DETAILS ARE ALSO APPLICABLE. THIS CURRENT REPORT PROVIDES THE CORRECTION BELOW. HER SECOND OPINION DOCTOR STRONGLY SUGGESTED THAT THE IOL GET EXPLANTED AND REPLACED WITH A MONOFOCAL IOL. THE EXPLANT FOR THE RIGHT EYE IS PLANNED FOR JANUARY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. THE PATIENT IS EXPERIENCING FLOATERS, RAINBOWS, HALOS AND STARBURST AROUND LIGHTS AND CHROME COLORED OBJECTS. PATIENT WAS DIAGNOSED WITH POSTERIOR CAPSULE OPACIFICATION AND HAD A YAG (YTTRIUM-ALUMINUM GARNET LASER TREATMENT) AND VITRECTOMY PROCEDURE. THE IMPLANTING DOCTOR INFORMED HER THAT SHE HAD ABNORMAL INFLAMMATION IN HER EYE AND REFERRED HER TO AN EXPERT. THE SECOND DOCTOR STATED THERE WAS NOTHING WRONG WITH HER EYES AND THAT IT WAS NORMAL INFLAMMATION. THE SYMPTOMS WERE NOTICED ¿RIGHT AFTER THE PROCEDURE¿ BUT THE EXACT DATE IS UNKNOWN. AFTER THE IMPLANTS SHE COULD NO LONGER DRIVE AT NIGHT. THE PATIENT REPORTED THAT THE ONLY REASON SHE DID THE IMPLANTS WAS FOR BETTER NIGHT VISION BUT IT¿S GOTTEN SIGNIFICANTLY WORSE SINCE THE IMPLANTS. SHE LIVES IN A PART OF THE COUNTRY WHERE IT GETS DARK VERY EARLY AND SHE CANNOT GO ANYWHERE UNLESS SHE IS DRIVEN. THE DOCTOR SAID HER BRAIN NEEDS TIME TO ADJUST BUT IT¿S BEEN TWO YEARS. THE PATIENT REVIEWED EXPLANTING THE IOLS WITH HER DOCTOR. REPORTEDLY, THE DOCTOR SAID, ¿IN 24 YEARS OF PRACTICE HE HAS NEVER SEEN A LENS REPLACEMENT AFTER A YAG.¿ THE DOCTOR SAID THAT HE CAN DO THE EXPLANTS BUT WILL ABORT THE PROCEDURE IF HE FEELS SOMETHING MAY GO WRONG. THE DOCTOR ALSO INFORMED HER THAT THE IOL CAN BE REPLACED BUT SHE WILL HAVE TO WEAR GLASSES. THE PATIENT DOES NOT ANTICIPATE ANY PROBLEMS AND SAID SHE IS A DISABLED BUT A HEALTHY 60-YEAR-OLD WOMAN. NO FURTHER INFORMATION WAS PROVIDED. NOTE, THE PATIENT'S EXPERIENCE FOR THEIR LEFT EYE IS REPORTED IN MANUFACTURER REPORT NUMBER: 3012236936-2024-0003069.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93428 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. DFR00V 05050474750661

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention