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

Catalog Number	8065751657
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/22/2024
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 during vitrectomy surgery puncture cannula cannot be moved flexibly.The surgery was completed on the same day with alternative product.Details of patient harm was not reported.
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation for the report of puncture cannula cannot be moved flexibly; therefore, the condition of the product could not be verified.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 photos attached to the parent file were reviewed by the manufacturing site.Photo show a label with reported lot number.Another photo show a trocar with hub circled.Reported issue cannot be confirmed from photos.A sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All trocar blades are 100% inspected.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information is provided.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information provided in sections b.2 and h.11.The initial decision to report was incorrect resulting in the initial report being submitted in error.This event code trocar blade dull or damaged is not considered to be a reportable malfunction, and it is not likely that a recurrence would result in serious injury.No further reports will be scheduled under mfg report num: 2028159-2024-00772.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: 19402595
• Report Number: 2028159-2024-00772
• Device Sequence Number: 7744368
• Product Code: NGY
• UDI-Device Identifier: 00380657516575
• UDI-Public: (01)00380657516575(17)240630(11)220726(10)14XJ4T(21)NA
• 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,Followup,Followup
• Report Date (Section B): 10/16/2024

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: 06/30/2024
• Device Catalogue Number: 8065751657
• Device Lot Number: 14XJ4T
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 07/28/2024; 08/24/2024; 09/17/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 08/24/2024; 09/21/2024; 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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