BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 12986568 · Received December 13, 2021

    Report

    Report Number
    3012236936-2021-00190
    Event Type
    Injury
    Date Received
    December 13, 2021
    Date of Event
    September 14, 2021
    Report Date
    October 26, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    POE
    UDI-DI
    05050474579149
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION H6: AS PART OF AN INTERNAL REVIEW OF OUR MDRS IT WAS IDENTIFIED THAT THE CODE(S) 4625 AND 2138 PROVIDED ON THE INITIAL REPORT NEEDS TO BE EXPLAINED IN SECTION H10 OF THE INITIAL REPORT WHICH WAS INADVERTENTLY MISSED. SECTION H10 THEREFORE WILL BE EXPLAINED HERE AS CORRECTION ON HEALTH EFFECT IMPACT CODE AND HEALTH EFFECT CLINICAL CODE IN INITIAL REPORT. SECTION H6: HEALTH EFFECT IMPACT CODE: 4625 ( SUTURES AND SECONDARY SURGICAL INTERVENTION). SECTION H6: HEALTH EFFECT CLINICAL CODE: 2138 (UNEXPECTED POST-OP REFRACTION AND VISUAL ACUITY DECREASED). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: RETURNED TO MANUFACTURER: YES. SECTION D9: DATE RETURNED TO MANUFACTURER: FEB 1, 2022. SECTION H3: EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE LENS WAS RECEIVED WITH NO VISIBLE ISSUES. THE LENS WAS CLEANED, AND NO ISSUES RELATED TO OR COULD HAVE CONTRIBUTED TO VISUAL ISSUES WERE OBSERVED. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED, AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH ADDITIONAL FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT WAS SEEN AGAIN BY THE DOCTOR ON (B)(6) 2021, BUT WAS NOT REFRACTED. UNCORRECTED VISUAL ACUITY (UCVA) 20/30, PH 20/25, UCNV J5. IT WAS REPORTED THAT THE PATIENT IS DOING WELL. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE INTRAOCULAR LENS (IOL) HAS NOT BEEN RECEIVED 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE (OS) DUE TO BLURRY VISION FOR DISTANCE. THE PATIENT¿S PRE-OPERATIVE (OP) VISUAL ACUITY WAS 20/50 AND POST-OPERATIVE UNCORRECTED VISUAL ACUITY WAS 20/50-2. THE DIAGNOSTIC RX (PRESCRIPTION) WAS -1.00 -0.25 X 118 20/20. THERE WAS A NINE-MONTH DELAY IN SURGERY. ADDITIONAL SURGICAL INTERVENTIONS OF INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT'S SYMPTOMS WERE FIRST NOTED DURING A DILATED EXAM. DUE TO THE MYOPIC ENDPOINT, THE PATIENT ENJOYED 4PT READING VISION OS AND POSTPONED ANY INTERVENTION FOR NINE-MONTHS. ANOTHER JOHNSON & JOHNSON IOL (SAME MODEL, DIFFERENT DIOPTER OF 21.0) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT DEVELOPED A LARGE HYPHEMA ON DAY ONE POST-OP VISIT. ON THE SECOND DAY POST-OP VISIT, THE PATIENT HAD AN ANTERIOR CHAMBER WASH OUT. DUE TO THE COMPLICATIONS OF THE HYPHEMA AND ADDITIONAL SURGERY, THE PATIENT'S VISION ON DAY ONE POST-OP WAS COUNTING FINGERS 1 FOOT (CF1'), AND ON DAY TWO POST-OP DISTANCE VISION (DV) WAS 20/200 PINHOLE (PH) NO IMPROVEMENT (NI), POTENTIAL ACUITY METER (PAM) 20/60. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1885098 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO PUERTO RICO MFG. INC. ZXR00 05050474579149

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention