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

Catalog Number	8065751586
Medical Device Problem Codes	Leak/Splash (1354); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A pharmacist reported that an ophthalmic trocar was not permeable during vitreoretinal surgery.The surgery was completed by an alternate product.There was no impact on 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
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stating ophthalmic trocar began to leak as soon as it was inserted in the patients eye.The details of patient impact was not reported.
Additional Manufacturer Narrative
One open trocar assembly, in a blister, with no tip protector, in a bag was received for the report of trocar was defective, it was not permeable.The trocar began to leak as soon as it was inserted in the eye.Sample was visually inspected and found to be nonconforming, blade was observed to have a bent tip, with part of the tip broken off.Penetration testing could not be performed due to the damage of the sample.Damaged septum, hole was observed in septum.Hub was observed to have a crack in it at the window area.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The exact root cause could not be determined from the investigation performed.The damage to the returned sample 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 sample could have contributed to the customer's reported issue of trocar was defective.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.A contributing factor to the hole in sample is that the probe was actuated during insertion/removal of the probe from the trocar cannula during surgery.Crack in the hub of trocar can be attributed to mishandling of device during surgery.The manufacturer internal reference number is: 2024-14170.

• 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: 18838050
• Report Number: 2028159-2024-00371
• Device Sequence Number: 12645613
• Product Code: NGY
• UDI-Device Identifier: 00380657515868
• UDI-Public: 00380657515868
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2024

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: 8065751586
• Device Lot Number: ASKU
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 03/15/2024; 05/26/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/12/2024; 06/21/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown