MAUDE Adverse Event Report: ALCON LENSX, INC. LENSX LASER SYSTEM; OPHTHALMIC FEMTOSECOND LASER

Model Number	550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A non-healthcare professional reported that a surgeon noticed a capsulotomy tear during the removal of cataract in right eye of the patient during refractive surgery.A vitrectomy was performed with an alternative three-piece mn6ac lens implantation.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6., and h.11.A manufacturing device history record review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.Service history was reviewed for the system.There were no service records (relevant to the reported event), found.However, the system was last serviced prior to the reported event per service record (sr).A number of contributing surgical factors (or variables) can contribute to the reported ¿capsular tear.¿ by proactively implementing preventive strategies to optimize surgical outcomes, surgeons will prioritize patient safety during cataract surgery procedures.However, based on the information obtained, the root cause of the reported event is inconclusive.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 ; 8007579780
• MDR Report Key: 24955079
• Report Number: 2028159-2026-00561
• Device Sequence Number: 20153169
• Product Code: OOE
• UDI-Device Identifier: 00380659981623
• UDI-Public: (01)00380659981623(17)220331(11)120331(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K163551
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 550
• Device Catalogue Number: 8065998162
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown