BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLY ADAPTIVE CATARACT TREATMENT SYSTEM

    MDR report key: 18322216 · Received December 13, 2023

    Report

    Report Number
    3009026057-2023-59360
    Event Type
    Injury
    Date Received
    December 13, 2023
    Date of Event
    November 13, 2023
    Report Date
    December 8, 2023
    Manufacturer
    LENSAR, INC
    Product Code
    OOE
    PMA / PMN Number
    K220259
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEASURE: THIS ISSUE ONLY IMPACTS THIS SPECIFIC DEVICE. PROCEDURE ID (B)(6) WAS REVIEWED. IT APPEARS THE TITANIUM ARM IS NOT LOCKED TO THE ROBOCONE. THE SUCTION RING IS WELL CENTERED. THERE IS EYE MOVEMENT THROUGHOUT THE PROCEDURE. EYE MOVEMENT COULD POTENTIALLY LEAD TO A CAPSULAR TEAR. NO FURTHER FOLLOW UP REQUIRED.

    Description of Event or Problem · 0

    ON 11/13/2023, WHILE ONSITE FOR SDA, DR. (B)(6) REPORTED A POSTERIOR RADIAL TEAR DURING PROCEDURE ID # (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273128 ALLY ADAPTIVE CATARACT TREATMENT SYSTEM ALLY ADAPTIVE CATARACT TREATMENT SYSTEM OOE LENSAR, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other