MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC; CANNULA, OPHTHALMIC

Catalog Number	8065149525
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that before a vitrectomy surgery an ophthalmic cannula silicone tip was missing from the tip of soft tip.Procedure was completed on same day.No patient harm was 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
A sample was not received at the manufacturing site for evaluation for the report of no silicone at the tip of soft tip; however, the attached photo confirms that soft tip was detached from the cannula.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 photo confirms no silicone at the tip of soft tip as reported by the customer.The root cause for the missing tip is related to the manual process of inserting, gluing, and cutting silicone tubing using the soft tip assembly machine.An investigation has been completed to investigate the returned non-conforming cannula.All soft tip cannula assemblies are 100% inspected by trained operators for the presence of and any damage to the soft tip.Also, all packages are 100% scanned by trained operators for damage to the blister package.Any non-conforming packages found are removed from the lot, torn down, and the packaging components are scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC
• Common Device Name: CANNULA, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17368958
• Report Number: 2523835-2023-00379
• Device Sequence Number: 7036607
• Product Code: HMX
• UDI-Device Identifier: 00380651495258
• UDI-Public: 00380651495258
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 12/05/2023

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 Catalogue Number: 8065149525
• Device Lot Number: 14C5U9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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