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

Catalog Number	8065751657
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
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 during a vitrectomy procedure on the right eye, the ophthalmic entry system was found to be leaking.Surgery was completed with no patient harm.
Additional Manufacturer Narrative
Corrected information is provided in section d.4.Additional information is provided in sections e.1, d.9, h.3, h.6 and h.11.Three opened trocar assemblies, in a surgical micro-puncture trocar (smpt), in a bag were received for the report of fluid leakage was observed from the valve during the procedure.Samples were visually inspected and found to be conforming.Functional leak testing was 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 were found to be visually and functionally conforming, therefore fluid leakage was observed from the valve during the procedure as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the trocars were manufactured to specifications.An acceptance quality inspection is performed to ensure product meets release acceptance criteria.This inspection includes evaluation for damaged valves.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No additional action is required at this time.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: 19738200
• Report Number: 2028159-2024-01021
• Device Sequence Number: 17066373
• Product Code: NGY
• UDI-Device Identifier: 00380657516575
• UDI-Public: (01)00380657516575(17)250430(11)230510(10)15LJ87(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 10/29/2024

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: 8065751657
• Device Lot Number: 15LJ87
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• 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