MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LENSX LASER SYSTEM; OPHTHALMIC FEMTOSECOND LASER

Model Number	550
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Failure to Align (2522)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that capsulotomy was decentered and as a result system generated an unexpected image in the right eye of the patient during refractive surgery.The treatment outcome was unfortunate but the patient is expected to do well postoperatively.There was no capsular tear and the surgeon did not re dock as well.He docked on the eye once and maintained suction in the entire procedure.Further the surgeon when pushed the advanced prepositioning button, the system should have prompted the device to capture an updated docked image but it did not.
Additional Manufacturer Narrative
H.3., h.6.: investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: LENSX LASER SYSTEM
• Common Device Name: OPHTHALMIC FEMTOSECOND LASER
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 24783857
• Report Number: 2028159-2026-00442
• Device Sequence Number: 6134018
• Product Code: OOE
• UDI-Device Identifier: 00380659981623
• UDI-Public: (01)00380659981623(17)310925(11)210927(10)1437D9
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K163551
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 550
• Device Catalogue Number: 8065998162
• Device Lot Number: 1437D9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VERION DIGITAL MARKER L
• Patient Age: 43 YR
• Patient Sex: Male