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

Catalog Number	8065751782
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation for the report of the metal part of the trocar was missing during surgery; 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 product was processed and released according to the product¿s acceptance criteria.A sample was not received at the manufacturing site and the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance 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.Assemblies are 100% inspected for adhesive application during assembly.If adhesive application is incorrect the assembly is scrapped.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported one of the trocars, at the time of removal during a procedure, the metal part was missing.A search for the metal part in the surrounding operative area and in the surgical area (inside the eye) was carried out with negative results.The customer indicated they will provide additional information when it becomes available.

• 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
• MDR Report Key: 11399803
• Report Number: 2028159-2021-00224
• Device Sequence Number: 3172274
• Product Code: NGY
• UDI-Device Identifier: 00380657517824
• UDI-Public: 380657517824
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2021

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: 10/31/2021
• Device Catalogue Number: 8065751782
• Device Lot Number: 13CVF0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR