BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 12200287 · Received July 20, 2021

    Report

    Report Number
    9614546-2021-07276
    Event Type
    Injury
    Date Received
    July 20, 2021
    Report Date
    July 20, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT AND ETHNICITY: INFORMATION UNKNOWN, NOT PROVIDED. DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS AUGUST 20, 2019. MODEL NUMBER: PARTIALLY KNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CATALOG NUMBER: A COMPLETE CATALOG NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: A COMPLETE UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. EXPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. MANUFACTURER TELEPHONE NUMBER: (B)(4). DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE SERIAL NUMBER OF THE COMPLAINT PRODUCT IS UNKNOWN. SINCE THE SERIAL NUMBER IS UNKNOWN, THE COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. CONCLUSION: SINCE THE SAMPLE OF THE COMPLAINT PRODUCT WAS NOT RETURNED, AND SERIAL NUMBER IS UNKNOWN, IT IS NOT POSSIBLE TO DETERMINE A MALFUNCTION AND/OR PRODUCT QUALITY DEFICIENCY. CITATION: LIU, X., SONG, X., WANG, W., ZHU, Y., LYU, D., SHENTU, X., CHEN, P., YU, Y., YAO, K. (2019). COMPARISON OF THE CLINICAL OUTCOMES BETWEEN ECHELETTE EXTENDED RANGE OF VISION AND DIFFRACTIVE BIFOCAL INTRAOCULAR LENSES. JOURNAL OF OPHTHALMOLOGY; VOLUME 2019, PP 1-9. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: COMPARISON OF THE CLINICAL OUTCOMES BETWEEN ECHELETTE EXTENDED RANGE OF VISION AND DIFFRACTIVE BIFOCAL INTRAOCULAR LENSES. A PROSPECTIVE, CONSECUTIVE, NONRANDOMIZED CLINICAL STUDY WAS DONE TO COMPARE THE CLINICAL OUTCOMES OF ECHELETTE EXTENDED RANGE OF VISION (ERV) AND DIFFRACTIVE BIFOCAL INTRAOCULAR LENSES (IOLS). A TOTAL OF 109 EYES OF 73 PATIENTS WITH CATARACT RECEIVED EITHER THE IMPLANTATION OF ECHELETTE ERV IOL TECNIS SYMFONY ZXR00 (N=56 EYES OF 38 PATIENTS) (JOHNSON & JOHNSON VISION) OR THE DIFFRACTIVE BIFOCAL IOL TECNIS ZMB00 (N=53 EYES OF 35 PATIENTS) (JOHNSON & JOHNSON VISION). IN THE EYES IMPLANTED WITH ZMB00, 1 EYE HAD NO IMPROVEMENT AND 1 EYE WORSENED. ONE FEMALE PATIENT, AGED (B)(6) YEARS OLD, WHO HAD HER RIGHT EYE IMPLANTED WITH ZMB00, DEMANDED IOL EXPLANT BECAUSE OF SEVERE GLARE. IN THE EYES IMPLANTED WITH ZMB00, 17 EYES WERE OCCASIONALLY SPECTACLE DEPENDENT AND 6 EYES WAS OFTEN SPECTACLE DEPENDENT. IN THE EYES IMPLANTED WITH ZXR00, 18 EYES WERE OCCASIONALLY SPECTACLE DEPENDENT AND 4 EYES WAS OFTEN SPECTACLE DEPENDENT. ADDITIONALLY, IT WAS REPORTED IN THE QUESTIONNAIRE ANALYSES THAT NEAR VISION WAS COMPROMISED IN ZXR00. FURTHER INTERVENTIONS WERE NOT REPORTED. REPORTED SUSPECT PRODUCT IS ZMB00 FOR PATIENT WITH SEVERE GLARE AND EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094270 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention