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

Catalog Number	8065000236
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 stopped producing spots.The surgeon was using a single spot probe when it stopped working.A new probe was installed and worked perfectly.Details of the procedure completion were not provided.There was no patient harm.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
The initial decision to report was incorrect resulting in the initial report being submitted in error.This event "single spot laser probe stopped producing spots" is not considered to be a reportable malfunction, and it is not likely that a recurrence would result in serious injury.No further reports will be submitted under mfg report num 2028159-2026-00396.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: 24712426
• Report Number: 2028159-2026-00396
• Device Sequence Number: 5726405
• Product Code: HQC
• UDI-Device Identifier: 00380650002365
• UDI-Public: (01)00380650002365(17)270608(11)250708(10)17HY62
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065000236
• Device Lot Number: 17HY62
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/21/2026
• 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