BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYS SYSTEM

    MDR report key: 11850000 · Received May 19, 2021

    Report

    Report Number
    3006695864-2021-07766
    Event Type
    Injury
    Date Received
    May 19, 2021
    Report Date
    May 19, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    OOE
    PMA / PMN Number
    K113479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS (B)(6) 2020 SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: A COMPLETE UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE SERIAL NUMBER OF THE COMPLAINT PRODUCT IS UNKNOWN. SINCE THE SERIAL NUMBER IS UNKNOWN, THE COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. SINCE THE SAMPLE OF THE COMPLAINT PRODUCT WAS NOT RETURNED, AND SERIAL NUMBER IS UNKNOWN, IT IS NOT POSSIBLE TO DETERMINE A MALFUNCTION AND/OR PRODUCT QUALITY DEFICIENCY. CITATION: RANI K, GROVER AK, SINGH AK, GROVER T, GARG SP. CORRECTION OF PREEXISTING ASTIGMATISM BY PENETRATING ARCUATE KERATOTOMY IN FEMTOSECOND LASER-ASSISTED CATARACT SURGERY. INDIAN J OPHTHALMOL 2020;68:1569-72. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: A NONRANDOMIZED PROSPECTIVE STUDY WAS DONE TO EVALUATE THE ASTIGMATISM CORRECTING EFFECT OF PENETRATING ARCUATE KERATOTOMY (AK) DONE DURING FEMTOSECOND LASER-ASSISTED CATARACT SURGERY (FLACS). A TOTAL OF 80 EYES OF 70 PATIENTS WITH CORNEAL ASTIGMATISM UNDERWENT COMBINED FLACS AND AK. THE CATALYS-I PRECISION LASER SYSTEM (OPTIMEDICA, JOHNSON & JOHNSON VISION) FEMTOSECOND LASER PLATFORM WAS USED IN THE STUDY TO PERFORM AK. IN ONE PATIENT, A SMALL CORNEAL PERFORATION (N=1) OCCURRED WHILE PERFORMING FSL-AK WHICH DID NOT RESULT IN ANY SEQUELAE. IT WAS ALSO REPORTED THAT UNDER CORRECTION IN AN UNSPECIFIED NUMBER OF PATIENTS WAS OBSERVED IN THE STUDY DUE TO THE GREATER REDUCTION IN THE LENGTH OF ARCUATE KERATOTOMY. THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747271 CATALYS SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE AMO MANUFACTURING USA, LLC CATALYS I

    Patients

    Seq Age Sex Outcome Treatment
    1 Other