MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER EDGEPLUS TROCAR/CANNULA SET; CANNULA, TROCAR, OPHTHALMIC

Catalog Number	8065751447
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
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 nurse reported that before cataract and vitrectomy combination surgery, the ophthalmic trocar tip damaged.The surgery was completed on the same day.There was no patient contact.
Additional Manufacturer Narrative
Additional information was provided in sections d.9, h.3 h.6 and h.11.Two opened trocar assemblies, one trocar handle blade assembly and one cannula/hub assembly, in a smpt, in a pouch were received for the report of trocar tip damaged.Sample 3 was visually inspected and was found to be nonconforming with tip of the trocar blade was broken off.Functional penetration testing was not performed due to damage of returned sample.Samples 1 and 2 were inspected visually inspected for trocar blade and both were found to be conforming.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The photo attached to the parent complaint was reviewed by the manufacturing site.The photo shows pak lot number, the reported product and lot information is confirmed.Reported issue cannot be confirmed from photo.The investigation conducted a non-conformance review of the reported lot number.No deviations were identified and all corresponding production release specifications defined in the device master record were met.The returned trocar blades were found to be visually conforming for samples 1 and 2 and based on the evaluation of the information and materials received for sample 3 confirms trocar blade damaged as noted by the customer.The damage to the returned sample 3 is consistent with damage that can occur when the blade contacts a hard surface such as the protective cap, improper handling, or contact with another instrument during surgery or set-up.The investigation was unable to identify the root cause or origin of the reported event.Additionally, no manufacturing-related deficiencies were found that potentially could have contributed to the complaint.Sample 1 and 2 met specifications and as the root cause and its origin are inconclusive for sample 3, further investigative or manufacturing actions are not warranted at this time.All trocar blades are 100% visually inspected.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaint data for all manufacturer products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: EDGEPLUS TROCAR/CANNULA SET
• Common Device Name: CANNULA, TROCAR, OPHTHALMIC
• 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: 22412595
• Report Number: 2028159-2025-00985
• Device Sequence Number: 8353417
• Product Code: NGY
• UDI-Device Identifier: 00380657514472
• UDI-Public: (01)00380657514472(17)270531(11)240619(10)16WC6P
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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): 10/10/2025

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: 8065751447
• Device Lot Number: 16WC6P
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• 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