BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLY ADAPTIVE CATARACT TREATMENT SYSTEM

    MDR report key: 24979922 · Received April 24, 2026

    Report

    Report Number
    3009026057-2026-00016
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    April 9, 2026
    Report Date
    April 17, 2026
    Manufacturer
    LENSAR, INC.
    Product Code
    OOE
    UDI-DI
    00867744000150
    PMA / PMN Number
    K220529
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PROCEDURE#: 1709 FILES SHOW A MANUAL ASTIGMATISM ENTRY OF 0.90 @ 7 AND MANUAL ARCUATE ENTRY OF 1 X 70 DEGREE ARCUATE @ 187. THE SYSTEM EXECUTED THE ARCUATE AS PROGRAMMED. REVIEW OF PROCEDURE #1965 SHOW A MANUAL ASTIGMATISM ENTRY OF 0.40 @ 174 AND A MANUAL ARCUATE ENTRY OF 1 X 60 @ 174. THE SYSTEM EXECUTED THE ARCUATE AS PROGRAMMED. RECOMMEND THE SITE VERIFY THE PRE-OP DATA, NOMOGRAM USED TO CALCULATE ARCUATE LENGTH AND AXIS AND THE SURGERY PLAN WITH THE SURGEON AND COMPARE IT TO THE VALUES ENTERED IN THE SYSTEM TO DETERMINE CAUSE OF REPORTED OVERCORRECTION. SYSTEM FUNCTIONED AS DESIGNED. THE SITE IS PLANNING POST OPERATIVE CARE FOR THE PATIENTS, WITH EITHER PROVIDING LASIK OR AN IOL EXCHANGE. NO FURTHER CLINICAL FOLLOW-UP REQUIRED.

    Description of Event or Problem · 0

    ON (B)(6) 2026, DOCTOR (B)(6) REPORTED TO CAS THAT THEY NOTED PROCEDURE IDS #1709 AND #1965 RESULTED IN AN OVERCORRECTION POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278873 ALLY ADAPTIVE CATARACT TREATMENT SYSTEM ALLY ADAPTIVE CATARACT TREATMENT SYSTEM OOE LENSAR, INC. N/A N/A 00867744000150

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other