BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 12230081 · Received July 27, 2021

    Report

    Report Number
    9614546-2021-07290
    Event Type
    Injury
    Date Received
    July 27, 2021
    Report Date
    July 26, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: EXACT AGES NOT PROVIDED, 57 +/- 6.2 YEARS. GENDER: 58% FEMALE. DATE OF EVENT: DATE ARTICLE ACCEPTED MARCH 25, 2021TELEPHONE NUMBER: (B)(6). (B)(4): THE INTRAOCULAR LENSES (IOL) ARE NOT RETURNING FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICES CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, LABELING, 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 MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. VILJANEN, A., KOSKELA, K., KOSKELA, H., TUUMINEN, R., AND UUSITALO, H. (2021). ONE-YEAR RESULTS OF HEALTH-RELATED AND VISION-RELATED QUALITY OF LIFE AFTER CLEAR LENS EXTRACTION AND MULTIFOCAL INTRAOCULAR LENS IMPLANTATION. AMERICAN JOURNAL OF OPHTHALMOLOGY. 2021;227 P. 241-243. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ONE-YEAR RESULTS OF HEALTH-RELATED AND VISION-RELATED QUALITY OF LIFE AFTER CLEAR LENS EXTRACTION AND MULTIFOCAL INTRAOCULAR LENS IMPLANTATION A PROSPECTIVE NONRANDOMIZED, NONCONTROLLED STUDY WAS DONE TO MEASURE THE HEALTH-RELATED QUALITY OF LIFE (HRQOL) AND VISION-RELATED QUALITY OF LIFE (VRQOL) AFTER CLEAR LENS EXTRACTION (CLE) AND MIOL IMPLANTATION. A TOTAL OF 137 PATIENTS WITH CATARACT WERE INCLUDED IN THE STUDY AND IMPLANTED WITH EITHER TECNIS + 3.25 BIFOCAL (JOHNSON & JOHNSON), TECNIS SYMFONY EXTENDED DEPTH OF FOCUS IOL (JOHNSON & JOHNSON), PANOP- TIX TRIFOCAL (ALCON), FINEVISION TRIFOCAL (PHYSIOL), OR AT LISA TRI TRIFOCAL (CARL ZEISS). IT WAS REPORTED THAT ND:YAG LASER CAPSULOTOMY (LCT) WAS PERFORMED ON 5.5% OF THE EYES, AND LASER REFRACTIVE ENHANCEMENT WAS PERFORMED ON 7% OF THE EYES DURING THE 1-YEAR FOLLOW- UP. REASON FOR THE INTERVENTIONS WERE NOT REPORTED. IT IS NOT CLEAR IF THESE INTERVENTIONS WERE PERFORMED IN THE EYES IMPLANTED WITH TECNIS + 3.25 BIFOCAL, TECNIS SYMFONY EXTENDED DEPTH OF FOCUS IOL OR THE OTHER PRODUCTS. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125087 TECNIS MULTIFOCAL POSTERIOR-CHAMBER INTRAOCULAR LENS, PSEUDOPHAKIC MFK AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention