BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 11515268 · Received March 18, 2021

    Report

    Report Number
    3006695864-2021-07350
    Event Type
    Injury
    Date Received
    March 18, 2021
    Report Date
    March 18, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. TELEPHONE NUMBER: UNKNOWN NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. 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.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: TITLE OF PUBLICATION : FEMTOSECOND LASER¿ASSISTED CATARACT SURGERY COMPARED WITH PHACOEMULSIFICATION CATARACT SURGERY: RANDOMIZED NONINFERIORITY TRIAL WITH 1-YEAR OUTCOMES. ALEXANDER C. DAY, PHD, JENNIFER M. BURR, MD, KATE BENNETT, MSC, CAROLINE J. DOR´E, BSC, CATEY BUNCE, DSC, RACHAEL HUNTER, MSC, MAYANK A. NANAVATY, PHD, KAMALJIT S. BALAGGAN, PHD, MARK R. WILKINS, MD, ON BEHALF OF THE FACT TRIAL GROUP. IT WAS REPORTED IN PUBLICATION, A MULTICENTER, RANDOMIZED CONTROLLED NONINFERIORITY TRIAL WAS DONE TO REPORT THE 1-YEAR OUTCOMES AND COMPARISON BETWEEN FEMTOSECOND LASER¿ASSISTED CATARACT SURGERY (FLACS) AND PHACOEMULSIFICATION CATARACT SURGERY (PCS). OF THE 785 PATIENTS ENROLLED AND RANDOMLY ASSIGNED, 292 PATIENTS IN THE FLACS ARM AND 311 PATIENTS IN THE PCS ARM WERE SUCCESSFULLY FOLLOWED UP AT 1-YEAR POST SURGERY. PATIENTS IN THE FLACS ARM WAS EITHER TREATED WITH CATALYS FEMTOSECOND LASER (JOHNSON & JOHNSON) OR LDV Z8 (ZIEMER OPHTHALMIC SYSTEMS AG). POSTOPERATIVE COMPLICATIONS OVER 1 YEAR FOR THE FLACS ARM INCLUDE POSTOPERATIVE ANTERIOR UVEITIS (N=38), MACULAR EDEMA (N=9), RETINAL TEAR OR DETACHMENT (N=2), STEROID RESPONSE OCULAR HYPERTENSION (N=7), MEDICATION ALLERGY OR INTOLERANCE (N=4), CORNEAL EDEMA (N=8), VITREOUS TO WOUND (N=1), POSTERIOR VITREOUS DETACHMENT (N=3), AND POSTERIOR CAPSULE OPACIFICATION (N=4). IN THE FLACS ARM, 304 PATIENTS WAS COLLECTIVELY REPORTED TO HAVE A MEAN ENDOTHELIAL CELL COUNT (ECC) LOSS BASELINE-FINAL CELLS/MM2 OF 228. IN ADDITION, 70 PATIENTS REPORTED HAVING SOME PROBLEM SEEING AND 6 PATIENTS REPORTED HAVING EXTREME PROBLEM SEEING. IT IS NOT CLEAR IF THE EVENTS OCCURRED ON THE EYES THAT WERE TREATED WITH CATALYS OR THE OTHER PRODUCT; NOR IS IT CLEAR IF THE EVENTS ARE DIRECTLY ATTRIBUTABLE TO THE DEVICE. THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418171 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other