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

Catalog Number 8065751782

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2020

Event Type  malfunction  

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.(b)(4).

Event 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.

Event Description

Additional information was received from the customer.The customer indicated they will provide additional information when it becomes available and the product sample is not available.

Manufacturer Narrative

Additional information provided in b.5.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The previous report submitted for this event contained an error in h.1.¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Manufacturer report number 2523835-2020-0277 was submitted in error.The original report was submitted under manufacturer report number 2523835-2020-0277.Please refer to manufacturer report number 2028159-2021-00224.No further reports will be submitted under manufacturer report number 2523835-2020-0277.The manufacturer internal reference number is: (b)(4).

• Brand Name: EDGEPLUS VALVED ENTRY SYSTEM
• Type of Device: CANNULA, TROCAR, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 10862733
• MDR Text Key: 218202933
• Report Number: 2523835-2020-00277
• Device Sequence Number: 1
• Product Code: NGY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 8065751782
• Device Lot Number: 13CVF0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR