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	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
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 customer reported that during a retinal detachment repair procedure on the right eye, two ophthalmic laser probes from the same batch became stuck in the trocar cannula, preventing smooth transition through the port.When the probe was pulled back, the trocar was pulled out along with it.The surgery was completed on the same day by replacing the probe with another one.No patient impact was reported.
Additional Manufacturer Narrative
Additional information 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.The 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 identified.A review for complaints reported against this lot number was performed.There was no relevant complaint found, as part of this investigation.The laser probe (lp) was received for testing.A visual assessment of the returned sample revealed no obvious nonconformity.The returned sample was connected to a calibrated opthalmic system and was successfully recognized.A fit check was performed with a trocar and resistance was found with the cannula.A visual assessment under a microscope was performed and revealed excess adhesive.The root cause of the reported event is attributed to excess adhesive.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: 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: 22209894
• Report Number: 2028159-2025-00874
• Device Sequence Number: 12926624
• Product Code: HQE
• UDI-Device Identifier: 00380657511143
• UDI-Public: (01)00380657511143(17)271031(11)241105(10)174LXN
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K946135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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: 174LXN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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 Age: 54 YR
• Patient Sex: Male