BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLY ADAPTIVE CATRACT TREATMENT SYSTEM

    MDR report key: 19792143 · Received July 22, 2024

    Report

    Report Number
    3009026057-2024-00029
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    June 5, 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
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXCESSIVE PATIENT MOVEMENT OBSERVED IS THE CAUSE FOR THE REPORTED FULL THICKNESS ARCUATE INCISION. IT IS RECOMMENDED THAT PROPER DOCKING AND PID LOCKING TECHNIQUE BE REVIEWED WITH THE USER. CLINICAL FOLLOW: DOCTOR USED INCISION NASALLY DURING PROCEDURE TO CLOSE AND IT WAS COMPLETED WITHOUT COMPLICATION.

    Description of Event or Problem · 0

    ON 06/27/2024, (B)(6) WAS REPORTED TO CASE THAT ON (B)(6) 2024, DOCTOR, EXPERIENCED A FULL THICKNESS ARCUATE INCISION NASALLY DURING PROCEDURE ID #(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2250611 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