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

Catalog Number	8065751447
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
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)(6).
Event or Problem Description
A non healthcare professional reported that the cannula of the puncture system will be left in the flat part of the sclera as a passage for intraocular instruments to enter and exit before surgery.The surgery was completed after replacing the product with another one.There was no patient harm.
Additional Manufacturer Narrative
Corrected information received and stated that the reported event of the puncture system will be left in the flat part of the sclera as a passage for intraocular instruments to enter and exit.Therefore, this event no longer meets reporting requirements, because a serious injury has not occurred, and it is not likely that a recurrence would result in serious injury.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Corrected information received and stated that the reported event of the puncture system will be left in the flat part of the sclera as a passage for intraocular instruments to enter and exit.Therefore, this event no longer meets reporting requirements, because a serious injury has not occurred, and it is not likely that a recurrence would result in serious injury.

• 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: 18070929
• Report Number: 2028159-2023-01516
• Device Sequence Number: 7769330
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

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: 10/31/2024
• Device Catalogue Number: 8065751447
• Device Lot Number: 145JR5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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
• Patient Sex: Unknown