MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER EDGEPLUS VALVED ENTRY SYSTEM; CANNULA, TROCAR, OPHTHALMIC

Catalog Number	8065751658
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
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 physician reported that an ophthalmic entry system did not stick and cut well during cataract, vitrectomy combination surgery.Surgery was completed after replacing the product with another one.There was no patient harm.
Additional Manufacturer Narrative
Additional information was provided in sections d.9, h.3, h.6 and h.11.Three opened 25 ga trocar assemblies were received for the report of product did not stick and cut well.Samples 1, 2 and 3 were inspected visually inspected for trocar blade and all were found to be conforming.Samples 1, 2 were visually inspected for cannula/ hub assembly and found to be conforming.Sample 3 was visually inspected and was found to be nonconforming with damaged septum/ angled slit.Dimensional ear width test was performed and was performed and all were found to be conforming.Functional penetration testing was then performed and all three samples 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 returned samples 1, 2 and 3 were conforming visually and dimensionally, therefore product did not stick well losse in incision) as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.The returned samples 1, 2 and 3 were conforming visually and functionally, therefore product did not cut well as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.Unrelated to the reported event, the trocar valve for sample 3 was found to be damaged.How and when the septum became damaged cannot be determined from the evaluation performed.A contributing factor to the damage in sample 3 is during insertion/ removal of the blade from the trocar cannula during surgery.Samples met specifications for the reported did not stick well and cut well issues and the exact root cause for damage to sample 3 is unknown therefore specific action for this complaint cannot be taken.The manufacturer internal reference number is: (b)(4).

• Brand Name: EDGEPLUS VALVED ENTRY SYSTEM
• 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: 21716522
• Report Number: 2028159-2025-00387
• Device Sequence Number: 11961238
• Product Code: NGY
• UDI-Device Identifier: 00380657516582
• UDI-Public: (01)00380657516582(17)260331(11)240422(10)16R473
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 8065751658
• Device Lot Number: 16R473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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