BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 15230361 · Received August 15, 2022

    Report

    Report Number
    3012236936-2022-02112
    Event Type
    Injury
    Date Received
    August 15, 2022
    Date of Event
    January 15, 2021
    Report Date
    August 15, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AGE OF THE 103 INCLUDED PATIENTS RANGED FROM 35 TO 75 YEARS. (48.5%) WERE MALE, 53 (51.5%) WERE FEMALE . DATE OF EVENT: EXACT DATE NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS JANUARY 15, 2021. MODEL NUMBER: THE EXACT MODEL IS UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED, ONLY INDICATED ZFR00. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. AS THE SERIAL NUMBER OF THE DEVICE IS UNKNOWN NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4). CITATION: GABRIC N., GABRIC I., GABRIC K, BI¿CEVIC A., PIÑERO D. P., BOHAC M. : CLINICAL OUTCOMES WITH A NEW CONTINUOUS RANGE OF VISION PRESBYOPIA-CORRECTING INTRAOCULAR LENS, JOURNAL OF REFRACTIVE SURGERY ¿ VOL. 37, NO. 4, 2021; 37(4): 256-262 ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE BELOW LITERATURE ARTICLE WAS RECEIVED WITH POTENTIAL COMPLICATIONS/AES REPORTED. TITLE: CLINICAL OUTCOMES WITH A NEW CONTINUOUS RANGE OF VISION PRESBYOPIA-CORRECTING INTRAOCULAR LENS A NON-RANDOMIZED PROSPECTIVE CASE STUDY WAS DONE TO EVALUATE THE CLINICAL OUTCOMES INCLUDING PATIENT-REPORTED OUTCOME MEASURES IN A SAMPLE OF EYES UNDERGOING BILATERAL CATARACT SURGERY WITH IMPLANTATION OF A NEW MODEL OF PRESBYOPIA-CORRECTING INTRAOCULAR LENS (IOL). A TOTAL OF 206 EYES OF 103 PATIENTS UNDERWENT PHACOEMULSIFICATION CATARACT SURGERY WITH BILATERAL IMPLANTATION OF THE TECNIS SYNERGY IOL (JOHNSON & JOHNSON VISION). AMONG THE RIGHT EYES IMPLANTED WITH TECNIS SYNERGY IOL, 1% LOST 2 SNELLEN LINES OF CORRECTED DISTANCE VISUAL ACUITY (CDVA) WHILE 2% LOST 1 SNELLEN LINE OF CDVA AMONG THE LEFT EYES. SIGNIFICANT POSTERIOR CAPSULAR OPACIFICATION WAS PRESENT IN 18 EYES AND ND: YTTRIUM ALUMINIUM GARNET (YAG) CAPSULOTOMY WAS REQUIRED MAINLY DUE TO DISTANCE VISION PROBLEMS. SIGNIFICANTLY WORSE 3-MONTH POSTOPERATIVE UNCORRECTED DISTANCE VISUAL ACUITY (UDVA) AND CDVA WAS FOUND IN THE GROUPS OF EYES WITH POSTERIOR CAPSULAR OPACIFICATION. DISTURBING HALOS WERE ONLY REPORTED BY 2 PATIENTS (WITH COMPLAINTS DURING NIGHT DRIVING IN ONLY 1 OF THESE 2 PATIENTS). SIGNIFICANT RESIDUAL CYLINDER ERROR WAS TREATED BY LASER CORNEAL REFRACTIVE SURGERY IN 4 EYES WHICH WAS RELATED TO WORSE VISUAL ACUITY OUTCOMES. THERE WERE 4 EYES (N=2 RIGHT EYES AND N=2 LEFT EYES) WITH 3-MONTH POSTOPERATIVE RESIDUAL ASTIGMATISM WHICH HAD A SIGNIFICANT NEGATIVE IMPACT ON UDVA AND NEAR VISUAL ACUITY UNDER LOW LIGHT OR LOW CONTRAST CONDITIONS. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509347 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZFR00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention