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

Catalog Number	8065000251
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
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 an ophthalmic laser probe could not be inserted into the trocar during a combined cataract and vitrectomy procedure.The surgery was successfully completed after the device was replaced with another one without impact to the patient.
Additional Manufacturer Narrative
Additional information is 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, a laser probe was returned for testing on this investigation.A non-conformance based review of the serial 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 serial number¿ was performed.No similar complaints were reported for this product serial number (under investigation).The laser probe was received for testing on this investigation.A visual assessment of the returned sample revealed no obvious nonconformities.The returned sample was connected to a calibrated module and was successfully recognized.A fit check was performed with a trocar and the mslp was unable to be inserted without resistance.Microscopic evaluation found excess adhesive accumulated around the distal end of the tip.However, how or when the excess adhesive was deposited on the tip remains inconclusive.The root cause of the reported event is attributed to excess adhesive at the tip.However, how or when the excess adhesive was deposited on the tip 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).
Additional Manufacturer Narrative
Additional information was provided in sections 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 similar complaints were reported for the product lot under investigation.The laser probe was returned for testing on this investigation.A visual assessment of the returned sample revealed the tip was damaged¿the curve of the tip was deflected outward.Microscopic evaluation found debris on the face and along the side of the distal tip; the optical fiber was protruding, and the illuminator fiber was slightly recessed.As received, the laser probe failed the 27ga trocar fit check.After successfully cleaning the tip, a fit check was reperformed, and the probe was successfully inserted without resistance.The root cause of the reported issue is attributed to debris found at the laser probe tip.However, how or when the debris accumulated on the tip 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 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: 23554716
• Report Number: 2028159-2025-01684
• Device Sequence Number: 10108008
• Product Code: HQC
• UDI-Device Identifier: 00380650002518
• UDI-Public: (01)00380650002518(17)270228(11)250310(10)179VXX
• 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,Followup
• Report Date (Section B): 05/25/2026

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: 8065000251
• Device Lot Number: 179VXX
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 03/04/2026; 05/01/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 03/30/2026; 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown