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

Catalog Number	8065751657
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during the ophthalmic surgery, the entry system was found to have fluid leakage.The patient's outcome was unknown.There was no harm to patient.
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).
Additional Manufacturer Narrative
Three open trocar assemblies, in a smpt, in bubble wrap, in a box were received for the report of fluid leakage.Samples were visually inspected and found to be nonconforming, sample 1 - damaged septum/ slit was observed to be torn at one end of the slit.Sample 2 and 3 - damaged septum/ angled slit was observed.Leak testing could not be performed due to the damage of the samples.A review of the device history record traceable to the possible lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The exact root cause for this complaint is unknown; the damaged condition of the valves could have contributed to the reported event; how and when the valves became damaged cannot be determined from the evaluation performed.The exact root cause for this complaint is unknown therefore specific action for this complaint cannot be taken.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).
Additional Manufacturer Narrative
Corrected information is provided in d.4.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: 19285268
• Report Number: 2028159-2024-00708
• Device Sequence Number: 15377096
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2024

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: 04/30/2024
• Supplement Date Received by Manufacturer: 08/04/2024; 09/02/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 09/02/2024; 10/01/2024
• 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