BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLY ADAPTIVE CATRACT TREATMENT SYSTEM

    MDR report key: 20268316 · Received September 20, 2024

    Report

    Report Number
    3009026057-2024-00040
    Event Type
    Injury
    Date Received
    September 20, 2024
    Date of Event
    August 21, 2024
    Report Date
    September 17, 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
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE SYSTEM DATA SHOWS THAT THE LASER CAPSULORHEXIS WAS COMPLETED WITHOUT ISSUE AND LASER FOUND TO HAVE FUNCTIONED AS DESIGNED. NO FURTHER CLINICAL FOLLOW UP OR INTERVENTION REQUIRED.

    Description of Event or Problem · 0

    (B)(4) - N/A - ISSUE: ON (B)(6) 2024, DR. ((B)(6)) REPORTED CAS THAT DURING PROCEDURE ID # (B)(6) THE CCI WAS THIN ON THE ANTERIOR FLAP AND WHEN ADVANCING THROUGH, IT WAS NOTED THE FLAP TORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1668193 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