BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLY ADAPTIVE CATRACT TREATMENT SYSTEM

    MDR report key: 19937949 · Received August 8, 2024

    Report

    Report Number
    3009026057-2024-00036
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    July 23, 2024
    Report Date
    August 1, 2024
    Manufacturer
    LENSAR, INC
    Product Code
    OOE
    PMA / PMN Number
    K220259
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LASER CAPSULORHEXIS WAS COMPLETED WITHOUT ISSUE AND LASER FOUND TO HAVE FUNCTIONED AS DESIGNED. NO FURTHER CLINICAL FOLLOW UP.

    Description of Event or Problem · 0

    ON (B)(6) 2024, WHILE CAS WAS ON-SITE FOR SURGERY SUPPORT, DR. (B)(6) EXPERIENCED A RADIAL TEAR ON PROCEDURE ID #20. THE AREA OF CONCERN WAS IN THE SUPERIOR NASAL REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327984 ALLY ADAPTIVE CATRACT TREATMENT SYSTEM ALLY ADAPTIVE CATRACT TREATMENT SYSTEM OOE LENSAR, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other