MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER UNITY TETRASPOT LASER PROBE; UNIT, PHACOFRAGMENTATION

Catalog Number	8065000236
Medical Device Problem Codes	Smoking (1585); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 customer reported that during surgery multi spot laser probe failed to fire laser and smoke was observed.The case was completed by providing a new laser probe for the surgeon.There were no patient injuries that occurred.
Additional Manufacturer Narrative
Additional information was provided in sections h.6 and h.11.The laser probe (lp) product under investigation is not a serviceable device.Therefore, a service record review was not performed.There was no lp returned on this investigation.Based on the information obtained, the root cause of the reported event is inconclusive.A manufacturing device history record (dhr) 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.A non-conformance based review of the serial number was performed.There were no relevant contributing factors identified.A review for complaints reported against this lot number was performed.No similar complaints were reported for the product lot under investigation with the same event code.Based on the information obtained, the root cause of the reported event is inconclusive.The manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: UNITY TETRASPOT LASER PROBE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• 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: 22356556
• Report Number: 2028159-2025-00951
• Device Sequence Number: 15617204
• Product Code: HQC
• UDI-Device Identifier: 00380650002365
• UDI-Public: (01)00380650002365(17)270114(11)250214(10)178VY0
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K233876
• 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): 09/17/2025

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 Catalogue Number: 8065000236
• Device Lot Number: 178VY0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/07/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 09/17/2025
• Date Device Manufactured: 02/14/2025
• 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