BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 18882814 · Received March 11, 2024

    Report

    Report Number
    3012236936-2024-00646
    Event Type
    Injury
    Date Received
    March 11, 2024
    Report Date
    March 11, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A2 AND A4: INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3 - DATE OF EVENT: EXACT DATE NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS 6 JULY 2023. SECTION D4 - CATALOG NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - SERIAL NUMBER: UNKNOWN/NOT PROVIDED. SECTION D4 - EXPIRATION DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - UDI NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A - IMPLANT DATE: INFORMATION UNKNOWN/NOT PROVIDED. SECTION D6B - EXPLANT DATE: N/A, DEVICE REMAINS IMPLANTED. SECTION G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE 1-PIECE IOL, MODEL ZCB00V THAT HAS A SIMILAR DEVICE, TECNIS 1-PIECE IOL MODEL ZCB00 WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. SECTION H3-OTHER (81): THE INTRAOCULAR LENS WAS NOT RETURNED FOR ANALYSIS. THE 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: NAGATA, M., MATSUSHIMA, H., MUKAI, K., SENOO, T., & NISHI, O. (2023). INHIBITION OF ANTERIOR CAPSULE OPACIFICATION AND CONTRACTION BY THE ELEVATED ANTERIOR RIM OF THE INTRAOCULAR LENS OPTIC. JAPANESE JOURNAL OF OPHTHALMOLOGY, 67(6), 693¿698. HTTPS://DOI.ORG/10.1007/S10384-023-01013-7 ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: INHIBITION OF ANTERIOR CAPSULE OPACIFICATION AND CONTRACTION BY THE ELEVATED ANTERIOR RIM OF THE INTRAOCULAR LENS OPTIC A RETROSPECTIVE COHORT STUDY WAS DONE TO VERIFY THE ANTERIOR CAPSULE OPACIFICATION (ACO) AND CONTRACTION (ACC) OF THE ZCB00V INTRAOCULAR LENS (IOL), MADE OF THE SAME MATERIAL AS THE AR40E WITH A HIGH ACC RATE. A TOTAL OF 69 EYES OF 35 PATIENTS DIAGNOSED WITH GRADE 2¿4 CATARACTS UNDERWENT PHACOEMULSIFICATION AND WERE IMPLANTED WITH EITHER A ZCB00V (N=35 EYES; JOHNSON & JOHNSON VISION) OR FY-60AD (N=34; HOYA SURGICAL OPTICS) IOL. AT 6-MONTHS POST-IOL IMPLANTATION, IT WAS REPORTED THAT THE ANTERIOR CAPSULE CONTRACTION (ACC) RATES (MEAN ± STANDARD DEVIATION) WERE AT 0.25 ± 2.36% AND THE ANTERIOR CAPSULE OPACIFICATION (ACO) PERCENTAGES (MEAN ± STANDARD DEVIATION) WERE DETERMINED TO BE 16.90 ± 8.34% IN THE ZCB00V GROUP. THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909516 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other