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

Catalog Number	8065149523
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2025
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)(4).H10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A nurse reported that during vitrectomy surgery an ophthalmic soft tip needle did not fit into the trocar.Procedure details and patient impact have not been provided.
Additional Manufacturer Narrative
Additional information provided in sections d.9., h.3., h.6., and h.11.One opened 23 ga soft tip, in a blister, with no sheathing, in a bag was received for the report of needle did not fit the trocar.The returned sample was visually inspected and was found to be non-conforming as there was no soft tip attached to the cannula.The sample's outer diameter was dimensionally inspected and was found to be within specification.A functional product fit test was performed using a lab provided trocar and was 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 returned was visually non-conforming as no soft tip was attached.How and when the soft tip of the cannula became detached/damaged cannot be determined from this evaluation.The returned sample was found to be dimensionally and functionally conforming, therefore a product fit issue with the trocar as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.A contributing factor could be if the soft tip was damaged and not completely torn off it could have contributed to not entering the trocar or a fit issue with in the trocar.The cannula met specifications dimensionally and functionally; however, the exact root cause for fit issue with the trocar and detached soft tip is unknown, therefore, specific action with regards to this complaint cannot be taken.All assemblies are 100% inspected by trained operators.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 additional action is required at this time.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 21583170
• Report Number: 2523835-2025-00264
• Device Sequence Number: 8895807
• Product Code: HMX
• UDI-Device Identifier: 00380651495234
• UDI-Public: (01)00380651495234(17)290331(11)240405(10)16P78V
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 06/13/2025

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: 8065149523
• Device Lot Number: 16P78V
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2024
• 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