BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 14719791 · Received June 16, 2022

    Report

    Report Number
    3012236936-2022-01562
    Event Type
    Injury
    Date Received
    June 16, 2022
    Report Date
    October 20, 2022
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE INFORMATION: PATIENT AGE AT TIME OF EVENT: UNKNOWN/ NOT PROVIDED. PATIENT DATE OF BIRTH AND GENDER: UNKNOWN/ NOT PROVIDED. PATIENT WEIGHT: UNKNOWN/ NOT PROVIDED. PATIENT ETHNICITY AND RACE: UNKNOWN/ NOT PROVIDED. DATE OF EVENT: DATE UNKNOWN/ NOT PROVIDED AND NO PUBLICATION DATE WAS AVAILABLE. 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 IT IS NOT AN IMPLANTABLE DEVICE INITIAL REPORTER PHONE NUMBER (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. 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. CITATION: TRINH, T., SOLOMON, B., MIMOUNI, M., COHEN, E., GOUVEA, L., SANTAELLA, G., SORKIN, N., ALSHAKER, S., DIN, N., & ROOTMAN, D. S. (2022). OUTCOMES OF FEMTOSECOND LASER¿ASSISTED CATARACT AND REFRACTIVE LENS SURGERY IN PATIENTS WITH PRIOR RADIAL KERATOTOMY. JOURNAL OF CATARACT AND REFRACTIVE SURGERY, 48(4), 449¿455. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION H6: HEALTH EFFECT - CLINICAL CODE: AS PART OF AN INTERNAL REVIEW OF OUR MDRS IT WAS IDENTIFIED THAT CODE 4581 WAS NOT DESCRIBED IN H10. CODE 4581 - EYE ANATOMY ISSUE. CODE 4581 - POSTERIOR CAPSULE OPACIFICATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. NOTE: ACKNOWLEDGEMENT 2 FOR THIS REPORT WAS RECEIVED ON 09/22/2022. THERE WAS A DELAY IN RECEIVING ACKNOWLEDGEMENT 3 DUE TO A CDRH SYSTEM ISSUE. MULTIPLE FOLLOW-UPS WERE CONDUCTED WITH THE ESG HELP DESK. ON (B)(6) 2022 ESG RESPONDED REQUESTING TO RESUBMIT THE MDR. THEREFORE, THIS REPORT IS BEING RESUBMITTED ON 10/20/2022.

    Description of Event or Problem · 0

    THE BELOW LITERATURE ARTICLE WAS RECEIVED WITH POTENTIAL COMPLICATIONS/AES REPORTED. ARTICLE TITLE: OUTCOMES OF FEMTOSECOND LASER-ASSISTED CATARACT AND REFRACTIVE LENS SURGERY IN PATIENTS WITH PRIOR RADIAL KERATOTOMY. THE LITERATURE REPORTS A SINGLE CENTER, WHERE RETROSPECTIVE OBSERVATIONAL CASE SERIES WAS DONE TO INVESTIGATE INTRA- AND POST-OPERATIVE OUTCOMES OF FEMTOSECOND LASER (FL-) ASSISTED CATARACT SURGERY (FLACS) AND REFRACTIVE LENS EXCHANGE (RLE) IN PATIENTS WITH PRIOR RADIAL KERATOTOMY (RK). A TOTAL OF NINE PATIENTS (N=16 EYES) WERE INCLUDED. ALL CASES USED THE CATALYS PRECISION FEMTOSECOND LASER SYSTEM (OPTIMEDICA, JOHNSON & JOHNSON (B)(4)). ANTERIOR CAPSULOTOMY WAS PERFORMED FOLLOWED BY LENS FRAGMENTATION AND LENS REMOVAL BY PHACOEMULSIFICATION USING EITHER THE INFINITI SYSTEM OR CENTURION SYSTEM (ALCON LABORATORIES, INC. (B)(4)) OR THE WHITESTAR SIGNATURE PRO (J&J VISION (B)(4)) PHACOEMULSIFICATION SYSTEM. MANUAL CLEAR CORNEAL INCISIONS POSITIONED AT THE SURGEON¿S DISCRETION WAS DONE AFTERWARDS. INTRAOPERATIVELY, ANTERIOR CAPSULAR TEARS (N= 2 EYES) WERE REPORTED. THE FIRST ANTERIOR CAPSULE TEAR EXTENDED TOWARDS THE LENS¿ EQUATOR BUT DID NOT RESULT IN A POSTERIOR CAPSULE TEAR, AND A SINGLE PIECE INTRAOCULAR LENS (IOL) WAS SUCCESSFULLY IMPLANTED. THE SECOND TEAR APPEARED STABLE. POSTOPERATIVELY, A CASE OF POSTERIOR CAPSULAR OPACIFICATION (N=1 EYE) DEVELOPED BUT DID NOT REQUIRE TREATMENT. THE SECOND OF THE ANTERIOR CAPSULE TEARS (N=1 EYE) THAT WAS STABLE ENOUGH AT THE TIME OF SURGERY LED TO A SUBLUXATED IOL, REQUIRING A SECOND REPARATIVE SURGERY. THE ANTERIOR CAPSULAR TEAR WAS FOUND AT THE 2 O'CLOCK POSITION WHERE THE FEMTOSECOND LASER WAS FOUND TO BE INCOMPLETE ON THE CAPSULORRHEXIS (DESPITE AN APPARENTLY COMPLETE LASER CAPSULOTOMY PROCESS). THERE WERE NO FURTHER INTERVENTIONS REPORTED. IT IS NOT CLEAR IF THE OTHER COMPLICATIONS WERE CAUSED BY CATALYS, OTHER JNJ PRODUCT, OR THE OTHER PRODUCTS MENTIONED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845847 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention