BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 11408425 · Received March 3, 2021

    Report

    Report Number
    9614546-2021-07085
    Event Type
    Injury
    Date Received
    March 3, 2021
    Report Date
    May 12, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    UDI-DI
    05050474606241
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER FOLLOW-UP, IT WAS CLARIFIED, THAT THE PATIENT EXPERIENCED EYE FATIGUE. AND NOT EYE FIGHTING ISSUE. MOREOVER, THE DOCTOR WAS (B)(6). ALSO, THE LENS WAS RETURNED FOR EVALUATION. AS A RESULT, THE FOLLOWING FIELDS HAVE BEEN UPDATED: SECTION E1: INITIAL REPORTER'S FIRST NAME, LAST NAME AND EMAIL ADDRESS: (B)(6); SECTION E2: HEALTH PROFESSIONAL: CORRECTED DATA: YES; SECTION E3: OCCUPATION: PHYSICIAN. ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES; SECTION D9: RETURNED TO MANUFACTURER ON: 3/16/2021; SECTION H3: DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED, VISCOELASTIC RESIDUE ON THE OPTIC BODY AND HAPTICS. WHICH IS CONSISTENT WITH A LENS, THAT WAS HANDLED DURING EXPLANT. THE LENS WAS CLEANED AND NO COSMETIC DEFECTS WERE OBSERVED. THE LENS WAS FORWARDED TO ANASCO, FOR DIOPTER MEASUREMENTS ON THE MIQ. AND THE LENS MEASURED WITHIN SPECIFICATIONS. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED. AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED, THAT NO OTHER COMPLAINT WAS RECEIVED FROM THIS PRODUCTION ORDER. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    UNKNOWN, INFORMATION NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS (B)(6) 2021 TWO WEEKS POST-IMPLANT AND TWO WEEKS BEFORE THE EXCHANGE PROCEDURE. INITIAL REPORTER NAME: UNKNOWN, INFORMATION NOT PROVIDED. PHONE NUMBER: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZXT300 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S OPERATIVE EYE AS IT APPEARED THAT THE LENS WAS OUT OF SPEC. PATIENT EXPERIENCED VERY BLURRY VISION, HEADACHES, AND EYE FIGHTING ISSUES, PATIENT OUTCOME NOTED AS POOR. INITIALLY DOCTOR HAD AIM AND PLAN CHOSEN WAS PLANO USING TORIC LENS, EXTENDED DEPTH OF FOCUS IOL TO GIVE THE PATIENT SPECTACLE INDEPENDENCE. POST OPERATIVE OUTCOMES AND DIAGNOSTICS REFLECTED THAT POWER OF LENS IS NOT REFLECTIVE OF THE LENS THAT WAS IMPLANTED. THE EVENT WAS OBSERVED DURING POST OPERATIVE EXAMINATION. THERE WAS A DELAY OF TWO WEEKS TO THE EXCHANGE. DOCTOR REMOVED THIS IOL AND IMPLANTED THE PATIENT WITH THE EXACT SAME POWER AND MODEL, AND PATIENT'S VISION IMPROVED IMMENSELY. PATIENT IS HAPPY NOW. AT EXCHANGE NO MEDICAL/SURGICAL INTERVENTIONS SUCH AS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE PERFORMED. VISUAL ACUITY PRE-OPERATIVE :UNCORRECTED: COUNT FINGERS, CORRECTED: 20/25. VISUAL ACUITY POST-OPERATIVE: UNCORRECTED: 20/400, CORRECTED: 20/25. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302108 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZXT300 05050474606241

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention