BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 18833097 · Received March 4, 2024

    Report

    Report Number
    3012236936-2024-00556
    Event Type
    Injury
    Date Received
    March 4, 2024
    Report Date
    March 4, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: AGE/DATE OF BIRTH (YEARS): AGES ARE 62.09 ± 8.64 SECTION A3: SEX/GENDER: (MALE: FEMALE): UNKNOWN, NOT PROVIDED. SECTION A4 & A5: INFORMATION UNKNOWN, NOT PROVIDED. SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS DECEMBER 7, 2022 SECTION D4: A COMPLETE CATALOG NUMBER IS UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI NUMBER: A COMPLETE UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A: IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6B: EXPLANT DATE: NOT APPLICABLE, AS LENS WAS NOT EXPLANTED. SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL LOT/SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: BRAR S, VANGA HR, SHAH ML, GANESH S. A PROSPECTIVE, RANDOMIZED, COMPARATIVE CLINICAL STUDY TO COMPARE THE SAFETY AND EFFICACY OF DIERENT HYDROPHOBIC ASPHERIC MONOFOCAL INTRAOCULAR LENSES. INDIAN J OPHTHALMOL 2023;71 :771-8. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    LITERATURE TITLE: A PROSPECTIVE, RANDOMIZED, COMPARATIVE CLINICAL STUDY TO COMPARE THE SAFETY AND EFFICACY OF DIFFERENT HYDROPHOBIC ASPHERIC MONOFOCAL INTRAOCULAR LENSES A PROSPECTIVE RANDOMIZED STUDY WAS DONE TO REPORT THE 1-YEAR CLINICAL OUTCOMES RELATED TO SAFETY, EFFICACY, PREDICTABILITY, CONTRAST SENSITIVITY, PATIENT SATISFACTION, COMPLICATIONS, AND OVERALL RESULTS WITH OPTIFLEX GENESIS AND EYECRYL PLUS (ASHFY 600) MONOFOCAL ASPHERIC INTRAOCULAR LENSES (IOLS) AND COMPARE THE SAME WITH TECNIS-1 MONOFOCAL IOL. A TOTAL OF 159 EYES OF 140 ELIGIBLE PATIENTS UNDERWENT CATARACT EXTRACTION WITH IOL IMPLANTATION WITH ANY OF THE THREE STUDY LENSES. OUT OF 159 EYES, 53 EYES WERE IMPLANTED WITH THE TECNIS-1 MONOFOCAL IOL. IN PATIENTS IMPLANTED WITH THE TECNIS-1 MONOFOCAL IOL, THE FOLLOWING WERE REPORTED AS MEAN ± STANDARD DEVIATION AT ONE-YEAR POST-OP: THE INTERNAL HIGHER ORDER ABERRATION (HOA) WAS FOUND TO BE AT -0.271±0.12MM, INTERNAL SPHERICAL ABERRATION (SA) WAS AT -0.261±0.02MM, INTERNAL COMA WAS AT -0.062±0.04MM, WHOLE EYE HOA WAS AT 0.105±0.05MM, AND WHOLE EYE SA WAS -0.008±0.02MM. IT WAS ALSO REPORTED THAT 2 EYES IN THE TECNIS GROUP HAD EVIDENCE OF VISUALLY SIGNIFICANT POSTERIOR CAPSULE OPACIFICATION (PCO), REQUIRING NEODYMIUM-DOPED YTTRIUM ALUMINUM GARNET (ND:YAG) CAPSULOTOMY AT THE END OF THE MEAN FOLLOW-UP. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196723 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention