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

Catalog Number	8065751593
Medical Device Problem Codes	Contamination (1120); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
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 nurse reported that an ophthalmic laser probe had hair wrapped around it and crowing on probe prevents it from coming between trocar before vitreoretinal surgery.The surgery was completed on the same day after replacing with another probe.No patient impact was reported.
Event or Problem Description
Upon further review, it was confirmed that curvature on an ophthalmic probe prevents it from coming out through the trocar before vitreoretinal surgery.
Additional Manufacturer Narrative
Corrected information was provided in section b5 and h6.Additional information was provided in sections d9 and h3.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in sections d4, 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 lot/batch/serial number was performed.A potentially relevant complaint was found and reviewed as part of this investigation.The complaint(s) was determined to not be relevant to this 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 system and was successfully recognized.A fit check was performed with a trocar and resistance was noted on the nitinol.The outer diameter of the cannula and the nitinol were both found to be conforming.A visual assessment under a microscope was performed and revealed an undersized nitinol radius.A calibrated smart scope was used to confirm the radius was undersized on the nitinol.After bending the nitinol slightly toward a straight position, the laser probe slid into the trocar without any resistance.The root cause of the reported event is attributed to an undersized nitinol radius.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Similar incident/event data was collected for the associated reported events.Quality assurance will continue to perform periodic monitoring 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: 19622723
• Report Number: 2028159-2024-00934
• Device Sequence Number: 15505177
• Product Code: HQE
• UDI-Device Identifier: 00380657515936
• UDI-Public: (01)00380657515936(17)250430(11)230508(10)15LAHD(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Followup
• Report Date (Section B): 11/26/2024

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 Expiration Date: 04/30/2025
• Device Catalogue Number: 8065751593
• Device Lot Number: 15LAHD
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 09/13/2024; 11/01/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 10/10/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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