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

Catalog Number	8065751658
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample has been received by manufacturing that has not yet been evaluated.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 during vitrectomy while using an ophthalmic trocar, leakage was observed.Surgery was completed on the same day and there was no patient harm.
Additional Manufacturer Narrative
Three opened ophthalmic trocar cannula hub assemblies in gauze within a pouch were received for the report of after introduced the valve cannulas to the patient s eye and after 30 minutes he had leakage from one canula.During this time period he introduced many times the vitrector and the light pipe.The returned sample #2 was visually inspected and was found to be non-conforming with a damaged septum with a hole observed.Leak testing could not be performed due to the damage of the sample.Samples #1 and #3 were visually inspected and were found to be conforming.The samples were then functionally leak tested and were found to be conforming.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 video given by the customer was reviewed by the manufacturing site.The video is of a eye surgery with three trocars seated in the eye, one can be seen with a hole at the septum, however no leakage was observed.The reported product complaint could not be confirmed.The exact root cause for sample#2 is unknown; the damaged condition of the valve could have contributed to the reported event; how and when the valve became damaged cannot be determined from the evaluation performed.Possible contributing factor to the damage septum is that the probe was actuated while moving in /out of the trocar cannula.The returned samples #1 and #3 were found to be visually and functionally conforming, therefore a leaking trocar as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.The exact root cause for sample #2 is unknown therefore specific action for this complaint cannot be taken.No action was taken for samples #1 and #3 as the trocars were manufactured to specifications.An acceptance quality inspection is performed to ensure product meets release acceptance criteria.This inspection includes evaluation for damaged valves.Complaints are reviewed and monitored at regular intervals to evaluate effectiveness of actions taken.No adverse trends have been observed associated with the reported product and event.No further actions are required.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: 16743081
• Report Number: 2028159-2023-00546
• Device Sequence Number: 6379320
• Product Code: NGY
• UDI-Device Identifier: 00380657516582
• UDI-Public: 00380657516582
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: 08/31/2023
• Device Catalogue Number: 8065751658
• Device Lot Number: 142YJT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION VISION SYSTEM.
• Patient Age: 49 YR
• Patient Sex: Female