BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLY ADAPTIVE CATRACT TREATMENT SYSTEM

    MDR report key: 18972049 · Received March 25, 2024

    Report

    Report Number
    3009026057-2024-00015
    Event Type
    Injury
    Date Received
    March 25, 2024
    Date of Event
    February 26, 2024
    Report Date
    March 25, 2024
    Manufacturer
    LENSAR, INC
    Product Code
    OOE
    PMA / PMN Number
    K182795
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. ADDITIONAL SURGICAL INTERVENTION WAS NOT REQUIRED.

    Description of Event or Problem · 0

    P1008 - N/A ISSUE: ON 02/26/2024, WHILE (B)(6) WAS ON SITE FOR SDA AT (B)(6), DR. (B)(6) REPORTED THAT HE HAD A RADIAL TEAR ON ID # (B)(6), THE TEAR WAS LOCATED AT THE INFERIOR TEMPORAL OS. ADDITIONAL SURGICAL INTERVENTION WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14074 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