MAUDE Adverse Event Report: Alcon LenSx, Inc. LENSX LASER SYSTEM; Ophthalmic Femtosecond Laser

Model Number	550
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during a creation of a flap, surgeon observed a thin flap in the unknown eye of the patient, during refractive surgery.Patient interface suction was successfully achieved and maintained until the end of the procedure.The patient did not move during the case.Although the flap was noted to be thin, it was successfully lifted, and the procedure was completed on the same day.
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.Alcon lensx (site #3008772169) is no longer operational.Lensx manufactured products are maintained and investigated by the alcon research, ltd.Irvine technology center site #2028159).The manufacturer internal reference number is: (b)(4).

• Brand Name: LENSX LASER SYSTEM
• Common Device Name: Ophthalmic Femtosecond Laser
• Manufacturer (Section D): Alcon LenSx, Inc.; 33 journey; suite #175; aliso viejo CA 92658
• Manufacturer (Section G): Alcon LenSx, Inc.; 33 journey; suite #175; aliso viejo CA 92658
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50883322
• Report Number: 2028159-2026-01510
• Device Sequence Number: 13218020
• Product Code: OOE
• UDI-Device Identifier: 00380659981623
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 02/28/2022
• Device Model Number: 550
• Device Catalogue Number: 8065998162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 02/29/2012
• 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