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

Model Number	550
Medical Device Problem Codes	Failure to Cut (2587); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A healthcare professional reported that system displayed optical coherence tomography error during docking and additionally flap was incomplete in the unknown eye of the patient during refractive surgery.Additional information has been requested.

• 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: 24895354
• Report Number: 2028159-2026-00507
• Device Sequence Number: 13381009
• Product Code: OOE
• UDI-Device Identifier: 00380659981623
• UDI-Public: (01)00380659981623(17)260412(11)160411(10)NA
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K163551
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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 Expiration Date: 04/12/2026
• Device Model Number: 550
• Device Catalogue Number: 8065998162
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2016
• 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
• Patient Sex: Unknown