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

Catalog Number	8065751658
Medical Device Problem Codes	Fitting Problem (2183); Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
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 physician reported that an ophthalmic trocar could not insert during combination of cataract/vitrectomy surgery.The surgery was completed with alternative product.Details of patient harm was not reported.Additional details has been requested and none received till date.Additional information received reporting that the surgery was completed on the same day.There was no patient harm.
Additional Manufacturer Narrative
Corrected information has been updated in h.6 the manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
One opened trocar assembly and 2 ophthalmic trocar handle blade assemblies, in a plastic tray, in a bag were received for the report of could not insert trocar.Samples were visually inspected and found to be conforming, no damage was observed to the trocar cannula.Surgical debris was observed inside the inner diameter of the cannula.The sample was then dimensionally inspected for cannula inner diameter and were found conforming.Blade sample 1 and 3 - tip of trocar blade was observed to be bent and has a damaged cutting edge.Blade sample 2 - trocar blade was observed to be bent and the tip of the blade was also broken off.A dimensional ear width measurement was performed and all three samples were found conforming.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The returned sample cannula were found to be visually and dimensionally conforming, therefore a product fit issue as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.However, the damage to the returned samples is consistent with damage that can occur when the blade contacts a hard surface such as the protective cap, improper handling, or contact with another instrument during surgery or set-up.The damage seen on the returned complaint samples could have contributed to the customers reported issue of dull blades 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.Any nonconformance, such as the damaged tip and cutting edges, are removed from the lot and scrapped.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: 19236751
• Report Number: 2028159-2024-00650
• Device Sequence Number: 8072137
• Product Code: NGY
• UDI-Device Identifier: 00380657516582
• UDI-Public: 00380657516582
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/05/2024

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 Catalogue Number: 8065751658
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 04/29/2024; 07/08/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 05/27/2024; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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