BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16440690 · Received February 24, 2023

    Report

    Report Number
    3012236936-2023-00297
    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
    P980040
    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. WEIGHT AND ETHNICITY: INFORMATION UNKNOWN/NOT PROVIDED. DATE OF EVENT: THE STUDY WAS CONDUCTED BETWEEN SEPTEMBER 3, 2007, AND DECEMBER 14, 2018, AND PATIENTS WERE FOLLOWED UNTIL DECEMBER 14, 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; AUGUST 17, 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 [TECNIS]; 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 ZCB00 LENS MODEL. SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER LENS MODELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870463 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other