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

Catalog Number	8065000237
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2025
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.A sample has been received by manufacturing that has not yet been evaluated.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during surgery two laser probes from the same lot would not fit into the trocar cannulas.Procedure details and patient harm was not reported.Additional information has been requested.
Additional Manufacturer Narrative
Additional information has been provided in sections d.9, h.3, h.6 and h.11.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, there were laser probes returned for testing.A non-conformance based review of the lot number was performed and did not reveal any potential contributing factors to the reported complaint.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 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.The laser probes were received for testing.For the first returned laser probe, there was no obvious visual nonconformities and aiming beam.When the tip was inserted in the appropriate trocar gauge, it was unable to be inserted.Further evaluation found excess adhesive at the tip.However, it remains inconclusive how or when the excess adhesive was deposited on the cannula.The second tip was able to be inserted into a trocar with no issues and met all testing specifications.The root cause of the reported event is attributed to excess adhesive for the first returned probe.However, it remains inconclusive how or when the excess adhesive was deposited on the cannula.The second returned probe was determined to meet specifications.Therefore, the root cause of the reported event is inconclusive.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: 23476808
• Report Number: 2028159-2025-01632
• Device Sequence Number: 18766626
• Product Code: HQC
• UDI-Device Identifier: 00380650002372
• UDI-Public: (01)00380650002372(17)270608(11)250708(10)17HY67
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K233876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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 Catalogue Number: 8065000237
• Device Lot Number: 17HY67
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• 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