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

Catalog Number	8065000237
Medical Device Problem Codes	Energy Output Problem (1431); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during cataract and vitrectomy surgery laser emission failure occurred and it was difficult to be inserted in an ophthalmic trocar for three of the ophthalmic laser probes from same lot.The surgery was completed on the same day after replacing the product with another one and there was no patient impact.
Additional Manufacturer Narrative
The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, a probe was returned for testing on this investigation.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 lot number was performed.There were no relevant contributing factors identified.A review for complaints reported against this lot number was performed.All relevant complaints found, were reviewed as part of this investigation.The probe was received for testing on this investigation.A visual assessment of the returned sample revealed some nonconformities.Probes 1 & 2 were determined to have a broken tip.Probe 3 had debris or damage on the tip.Functional testing was unable to be performed due to these findings.How or when the tips became damaged remains inconclusive.Based on the information obtained, the root cause of the reported event is inconclusive.How or when the tips became damaged remains 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: 22585469
• Report Number: 2028159-2025-01088
• Device Sequence Number: 9492897
• Product Code: HQC
• UDI-Device Identifier: 00380650002372
• UDI-Public: (01)00380650002372(17)261223(11)250123(10)177TYF
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 12/04/2025

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: 8065000237
• Device Lot Number: 177TYF
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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