BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16440689 · Received February 24, 2023

    Report

    Report Number
    3012236936-2023-00296
    Event Type
    Injury
    Date Received
    February 24, 2023
    Report Date
    February 24, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE/DATE OF BIRTH: NO EXACT AGES WERE PROVIDED, MEAN [SD] AGE 73.2 [8.6] YEARS AT THE FIRST SURGERY AND 74.3 [8.8] YEARS AT THE SECOND SURGERY GENDER: 4986 PATIENTS WERE INCLUDED IN THE ANALYSIS, (1707 [34.2%] MEN AND 3279 [65.8%] WOMEN INFORMATION UNKNOWN/NOT PROVIDED. DATE OF EVENT: THE STUDY WAS CONDUCTED BETWEEN SEPTEMBER 3, 2007, AND DECEMBER 14, 2018, AND PATIENTS WERE FOLLOWED UNTIL (B)(6) 2021 CATALOG NUMBER: 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: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN/ NOT PROVIDED EXPLANT DATE: N/A, LENS REMAINS IMPLANTED DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. DEVICE EVALUATION PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED (THE LENS REMAINS IMPLANTED). THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED, AND THE REPORTED EVENT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED, AND COMPLAINT HISTORY WERE NOT REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. CITATION: KANCLERZ, P.; HECHT, I.; CUNHA, M.; KNYAZER, B.; LAINE, I.; TUUMINEN, R.; ASSOCIATION OF BLUE LIGHT¿FILTERING INTRAOCULAR LENSES WITH ALL-CAUSE AND TRAFFIC ACCIDENT¿RELATED INJURIES AMONG PATIENTS UNDERGOING BILATERAL CATARACT SURGERY IN FINLAND; (B)(6) 2022. DOI:10.1001/JAMANETWORKOPEN.2022.27232 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: ASSOCIATION OF BLUE LIGHT-FILTERING INTRAOCULAR LENSES WITH ALL-CAUSE AND TRAFFIC ACCIDENT-RELATED INJURIES AMONG PATIENTS UNDERGOING BILATERAL CATARACT SURGERY IN FINLAND A RETROSPECTIVE REGISTRY-BASED COHORT STUDY WAS DONE TO ASSESS THE ASSOCIATION OF BLUE LIGHT-FILTERING (BLF) INTRAOCULAR LENSES (IOLS) WITH ALL-CAUSE AND TRAFFIC ACCIDENT¿RELATED INJURIES AND QUALITY OF VISION WHILE DRIVING AFTER BILATERAL CATARACT SURGERY. PATIENTS (N= 4,986 PATIENTS; N= 9,972 EYES) WHO UNDERWENT PHACOEMULSIFICATION SURGERY AND IN-THE-BAG IMPLANTATION OF NON-BLF IOLS (ZA9003 AND ZCB00/PCB00 [TECHNICS]; ABBOTT MEDICAL OPTICS JOHNSON & JOHNSON VISION, INC) (N= 2,609 PATIENTS; N= 5218 EYES) OR BLF IOLS (SN60WF/AU00T0 [ACRYSOF]; ALCON LABORATORIES INC) (N= 2,377 PATIENTS; N=4,754 EYES) IN BOTH EYES WERE INCLUDED. THERE WERE 193 PATIENTS OF THOSE WHO UNDERWENT UNEVENTFUL CATARACT SURGERY THAT WERE CURRENTLY DRIVING A CAR; THEY WERE GROUPED INTO NON-BLF IOLS (N=102 PATIENTS) AND BLF IOLS (N=91 PATIENTS). INJURIES DURING THE POSTOPERATIVE FOLLOW-UP PERIOD INCLUDED: HEAD (N=148) NECK (N=6) THORAX (N=34) ABDOMEN, LOWER BACK, LUMBAR SPINE, PELVIS, AND EXTERNAL GENITALS (N=41) SHOULDER AND UPPER ARM (N=84) ELBOW AND FOREARM (N=99) WRIST, HAND, FINGERS (N=62) HIP AND THIGH (N=131) KNEE AND LOWER LEG (N=88) ANKLE AND FOOT (N=34) TRAFFIC-ACCIDENT-RELATED (N=12) OTHER COMPLICATIONS INCLUDED: AVOID DRIVING OWING TO VISUAL DISTURBANCES (39.2%) AVOID DRIVING AT EVENING OR NIGHT (18.6%) HALOS (29.4%) VISUAL DISTURBANCES WITH HEADLIGHTS (19.6%) DIFFICULTIES READING ROAD SIGNS (4.9%) DIFFICULTIES SPOTTING PEDESTRIANS (3.9%) QUALITY OF DRIVING: POOR (1%); MODERATE (31.4%); GOOD (55.9%) GLARE AT DRIVING IN DAYTIME: RARELY (19.6%); OCCASIONALLY (9.8%); ALWAYS (1%) GLARE AT DRIVING AT EVENING OR NIGHT: RARELY (14.5%); OCCASIONALLY (12.0%); OFTEN (7.2%) THERE WERE NO FURTHER INTERVENTIONS REPORTED. IT WAS NOT CLEAR IF THE COMPLICATIONS REPORTED WERE DUE TO THE J&J DEVICE, OTHER DEVICE OR OTHER FACTORS IN THE ARTICLE. THIS SUBMISSION IS FOR THE ZA9003 LENS MODEL. SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER LENS MODELS. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870462 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other