BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 14718604 · Received June 16, 2022

    Report

    Report Number
    3012236936-2022-01550
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    June 24, 2021
    Report Date
    July 12, 2022
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE AT TIME OF EVENT: UNKNOWN. DATE OF BIRTH AND GENDER: UNKNOWN. PATIENT WEIGHT: UNKNOWN. ETHNICITY AND RACE: UNKNOWN. DATE OF ACCEPTANCE USED AS DATE OF EVENT: JUNE 24, 2021. SERIAL NUMBER#: UNKNOWN/NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI #: A COMPLETE UDI # IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: NOT APPLICABLE AS PRODUCT IS NOT AN IMPLANTABLE DEVICE MANUFACTURE DATE: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED; THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE ARTICLE CITATION WAS NOT INCLUDED IN THE INITIAL REPORT. KOENIG, L. R., DUONG, A. T., YUAN, M., & VAN TASSEL, S. H. (2022). ADVERSE EVENTS ASSOCIATED WITH FEMTOSECOND LASER¿ASSISTED CATARACT SURGERY REPORTED TO THE MAUDE DATABASE. JOURNAL OF CATARACT AND REFRACTIVE SURGERY, 48(2), 168¿172.

    Description of Event or Problem · 0

    THE BELOW LITERATURE ARTICLE WAS RECEIVED ON A LITERATURE REVIEW: LITERATURE TITLE: ADVERSE EVENTS ASSOCIATED WITH FEMTOSECOND LASER-ASSISTED CATARACT SURGERY REPORTED TO THE MAUDE DATABASE. A STUDY WAS DONE TO REPORT REAL-WORLD COMPLICATIONS ASSOCIATED WITH FEMTOSECOND LASER¿ASSISTED CATARACT SURGERY (FLACS). A TOTAL OF 1,927 REPORTS WERE INCLUDED IN THE STUDY AND WERE EITHER TREATED WITH THE LASER SYSTEM LENSX (N=1202 REPORTS; ALCON LABORATORIES, INC.), CATALYS (N=578 REPORTS; JOHNSON & JOHNSON VISION), LENSAR (N=135 REPORTS; LENSAR, INC.), OR OTHER/UNKNOWN (N=12 REPORTS). INTRAOPERATIVE COMPLICATIONS INCLUDE THE FOLLOWING: CAPSULE TEARS NOT REQUIRING VITRECTOMY (N=786; ANTERIOR CAPSULE TEAR N=474, POSTERIOR CAPSULE TEAR N=241, AND CAPSULE TEAR NOT OTHERWISE SPECIFIED N=71). CAPSULE TEARS REQUIRING VITRECTOMY (N=329; POSTERIOR CAPSULE TEAR WITH ANTERIOR VITRECTOMY N=282, POSTERIOR CAPSULE TEAR WITH POSTERIOR VITRECTOMY N=46, AND CAPSULE TEAR WITH VITRECTOMY NOT OTHERWISE SPECIFIED N=1). SUCTION LOSS 372 (13.8). OTHER CAPSULOTOMY-RELATED COMPLICATIONS (IE, INCOMPLETE AND TAG) (N=321). WOUND LEAK (N=72). CORNEAL LACERATION AND PERFORATION (AT THE TIME OF INCISION) (N=65). INCORRECT SPECIFICATION (EG, DEPTH, LOCATION, SIZE, AND WIDTH) (N=59). INCOMPLETE INCISION (N=31). DESCEMET MEMBRANE TAG OR DETACHMENT (N=68). CORNEAL EPITHELIAL DAMAGE (N=24). CORNEAL ENDOTHELIAL DAMAGE (N=12). UNINTENDED GANTRY MOVEMENT (N=83). CASE ABORTED (N=107). MIOSIS (N=54). POSTOPERATIVE COMPLICATIONS INCLUDE THE FOLLOWING: ENDOPHTHALMITIS (N=14). TOXIC ANTERIOR SEGMENT SYNDROME (TASS) (N=6). CORNEAL EDEMA (N=32). CORNEAL ULCER/MELT/INFILTRATE (N=6). CORNEAL INFLAMMATION (N=5). ADDITIONAL RARE COMPLICATIONS REPORTED INCLUDE UNPLANNED EYE PERFORATION (N=1), EYELID LACERATION THAT WAS REPAIRED BY THE PHYSICIAN (N=1), ONE NURSE BEING HARMED BY A METAL SPLINTER BECOMING IMBEDDED IN THE NURSE¿S FINGER WHILE ASSISTING WITH THE PROCEDURE (N=1), AND GAS BUBBLE MIGRATING INTO A CORNEAL TRANSPLANT DUE TO A LASER INCISION, WHICH REQUIRED SURGICAL REPAIR (N=1). IT IS NOT CLEAR IF THESE COMPLICATIONS OCCURRED IN THE EYES TREATED WITH CATALYS (JOHNSON & JOHNSON VISION) OR THE OTHER PRODUCTS. NO FURTHER INFORMATION WAS PROVIDED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795748 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention