MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER EDGEPLUS TROCAR/CANNULA SET; CANNULA, TROCAR, OPHTHALMIC

Catalog Number	8065751447
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that an ophthalmic operating needle unable to remove before the vitrectomy surgery.The patient harm was not reported.
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
Two open trocar assemblies & one handle blade assembly with cannula only attached, in a smpt.In a pouch were received, for the report of needle head unable to remove.Samples #1 and #2 were visually inspected and found conforming.A functional fit test was conforming, for sample #1 and #2.As blade was able to be separated from cannula.Sample #3 was visually inspected and found nonconforming, hub was missing from the cannula.Cannula had nick on the top of the flange.All three samples were then dimensionally inspected, for cannula inner diameter and were found conforming.Dimensional testing for ear width was performed, for all three samples and found conforming.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.The photo attached to the parent file was reviewed by the manufacturing site.Photo show a label with reported lot number.Reported issue cannot be confirmed, from photo.The returned samples were found to be 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.No action was taken, as the trocar was manufactured to specifications.All trocar assemblies are 100% inspected, for gage size and blade damage.Any non-conformances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed, associated with the reported product and event.No further actions are required.The manufacturer internal reference number (b)(4).

• Brand Name: EDGEPLUS TROCAR/CANNULA SET
• 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: 18300107
• Report Number: 2028159-2023-01655
• Device Sequence Number: 7152221
• Product Code: NGY
• UDI-Device Identifier: 00380657514472
• UDI-Public: 00380657514472
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2024

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 8065751447
• Device Lot Number: 15CT30
• 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: 11/14/2023
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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