MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LASER PROBES; INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED

Catalog Number	8065751114
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
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.(b)(4).
Event or Problem Description
A nurse reported that an ophthalmic laser probe could not enter cannula during vitrectomy surgery.Surgery was completed after changing product with a new one.No patient impact was reported.
Additional Manufacturer Narrative
Additional information was 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 (lp) 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.A review for complaints reported against this lot number was performed.There were no relevant complaints found, as part of this investigation.There was a laser probe received for testing on this investigation.A visual assessment of the returned sample revealed a detached nitinol.The returned sample was connected to a calibrated system and was successfully recognized.The returned sample was connected to a calibrated system but had a recognition failure.Further analysis found foreign substance adhered to the cannula.However, as to how or when it became damaged remains inconclusive.The cannula portion of the laser probe was found damaged.How or when tip became damaged remains inconclusive.Thus, based on the information obtained, 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: LASER PROBES
• Common Device Name: INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED
• 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: 21950516
• Report Number: 2028159-2025-00662
• Device Sequence Number: 12934520
• Product Code: HQE
• UDI-Device Identifier: 00380657511143
• UDI-Public: (01)00380657511143(17)270531(11)240603(10)16V73F
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K946135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: 8065751114
• Device Lot Number: 16V73F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2024
• 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