BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 11625594 · Received April 6, 2021

    Report

    Report Number
    3006695864-2021-07424
    Event Type
    Injury
    Date Received
    April 6, 2021
    Report Date
    April 6, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH, WEIGHT AND ETHNICITY: INFORMATION UNKNOWN/ NOT PROVIDED. DATE OF EVENT: DATE UNKNOWN/ NOT PROVIDED MODEL #: UNKNOWN/NOT PROVIDED. SERIAL # UNKNOWN/ NOT PROVIDED. EXPIRATION DATE, UDI #: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. SIGNATURE PHACOFRAGMENTATION, ZMA00 IOL, ZLB00 IOL. TELEPHONE NUMBER: UNKNOWN/ NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. H3-81 DEVICE EVALUATION: THE CATALYS SYSTEM WAS NOT IDENTIFIED AND COULD NOT BE EVALUATED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE CATALYS SYSTEM COULD NOT BE REVIEWED AS THE SERIAL NUMBER WAS NOT PROVIDED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. ARTICLE: POSTERIOR CAPSULE RUPTURE WITH FLACS DUE TO ERRONEOUS INTERPRETATION OF A HIGH OCT INTENSITY AREA IN ANTERIOR VITREOUS CITATION: (B)(6) * , (B)(6); POSTERIOR CAPSULE RUPTURE WITH FLACS DUE TO ERRONEOUS INTERPRETATION OF A HIGH OCT INTENSITY AREA IN ANTERIOR VITREOUS; DEPARTMENT OF OPHTHALMOLOGY, (B)(6) UNIVERSITY, SCHOOL OF MEDICINE, (B)(6); AMERICAN JOURNAL OF OPHTHALMOLOGY CASE REPORTS (19) (2020) 100811.

    Description of Event or Problem · 1

    PER A LITERATURE ARTICLE IN (B)(6), A CASE REPORT WAS DONE TO DESCRIBE A NOVEL CASE OF POSTERIOR CAPSULE RUPTURE DURING FEMTOSECOND LASER-ASSISTED CATARACT SURGERY (FLACS) DUE TO DIRECT EXPOSURE OF THE POSTERIOR CAPSULE TO THE LASER BEAM, IN A (B)(6) YEAR OLD MALE WHO UNDERWENT FLACS FOR A ANTERIOR CAPSULE OPACITY. THE CATALYS SYSTEM DETECTED AN ARC-SHAPED HIGH-INTENSITY AREA BEHIND THE POSTERIOR CAPSULE AND WAS MISINTERPRETED AS THE POSTERIOR CAPSULE ITSELF, WHICH LED TO THE ERROR IN APPLICATION OF LASER BEAM DURING THE PROCEDURE. HOWEVER, THE FEMTOSECOND LASER IRRADIATION WAS PRESUMED TO BE COMPLETED SUCCESSFULLY, AND THE SURGEON PROCEEDED WITH THE SURGERY. UPON INSERTION OF THE PHACO-TIP, THE DICED NUCLEUS OF THE LENS DROPPED INTO THE VITREOUS CHAMBER. ANTERIOR VITRECTOMY WAS PERFORMED, ALL REMNANTS OF THE NUCLEUS WITHIN VISIBLE RANGE WERE REMOVED, AND THE EYE WAS INITIALLY LEFT APHAKIC. ON POST-OPERATIVE DAY 14, A SULCUS-FIXATED IOL WAS INSERTED. THE OPERATOR PERFORMED FLACS WITH A ZLB00 + 11.5D LENS FOR THE PATIENT¿S LEFT EYE ON THE NEXT DAY. AN AUTOMATIC ALIGNMENT FOR THE POSTERIOR CAPSULE FAILED AGAIN BECAUSE AN ARC-SHAPED HIGH OCT INTENSITY AREA ALSO EXISTED IN THE LEFT EYE. THE OPERATOR FIXED THE ALIGNMENT CAREFULLY AND COMPLETED THE SURGERY WITHOUT ANY COMPLICATIONS. OTHER JOHNSON & JOHNSON PRODUCTS WERE MENTIONED, BUT NO COMPLAINTS WERE REPORTED AGAINST THEM. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514668 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention