BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLY ADAPTIVE CATRACT TREATMENT SYSTEM

    MDR report key: 19778637 · Received July 18, 2024

    Report

    Report Number
    3009026057-2024-00027
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    June 19, 2024
    Report Date
    July 16, 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
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SOFTWARE AND FIELD SERVICE TEAMS EACH CONFIRMED THE SYSTEM IS WITHIN SPECIFICATIONS, AND THAT THE ANATOMICAL SURFACES WERE CORRECTLY IDENTIFIED. PATIENT ID (B)(6) DID INDICATE SLIGHT PATIENT MOVEMENT, BUT THE SURGEON REPORTED THE CAPSULOTOMY WAS COMPLETE. PATIENT ID (B)(6) SHOWED SOME PATIENT MOVEMENT AS WELL, BUT THE SURGICAL FOOTAGE WAS AVAILABLE, AND THE CAPSULOTOMY AND FRAGMENTATION LOOKED NORMAL. IT IS UNCLEAR WHAT CAUSED THE RUPTURE. SEVERAL PROCEDURES HAVE BEEN COMPLETED BY OTHER SURGEONS BOTH BEFORE AND AFTER THESE EVENTS WITH NO ISSUES REPORTED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, (B)(6) REPORTED TOCAS THAT DR. EXPERIENCED TWO POSTERIOR TEARS WHILE HYDRODISSECTION ON THE FEMTO LENS: PROCEDURE ID (B)(6) ON (B)(6) 2024 AND (B)(6) ON (B)(6) 2024. IT WAS STATED THAT THE PATIENTS HAD NO HISTORY OF TRAUMA OR PAST RETINAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555860 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