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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
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 is available that has not yet been received at manufacturing for evaluation the manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during the demonstration of an opthalmic laser probe did not fit into the trocar.There was no patient involvement.
Additional Manufacturer Narrative
Correction information provided in section h.6.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in section 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, a laser probe was returned for testing on this investigation.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.There were no relevant complaints found, as part of this investigation.The mslp was received for testing.A visual assessment of the returned sample revealed no obvious nonconformity.The returned sample was connected to a calibrated system and was successfully recognized.A fit check was performed with a trocar and the laser probe was unable to be inserted without resistance.A visual assessment under a microscope was performed and revealed excess adhesive at the tip.The root cause of the reported event is attributed to excess adhesive.However, it remains inconclusive how or when the excess adhesive was deposited on the cannula.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: 23497767
• Report Number: 2028159-2025-01656
• Device Sequence Number: 8858269
• Product Code: HQC
• UDI-Device Identifier: 00380650002372
• UDI-Public: (01)00380650002372(17)270414(11)250514(10)17EC7A
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K233876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2026

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: 17EC7A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 11/14/2025; 01/21/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/08/2025; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• 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