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).
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
The returned sample was visually inspected and was found to be non-conforming as the soft tip is torn but not completely in two pieces as it is still attached.A dimensional inspection was performed for the cannula outer diameter and was found to be within specification.The sample was then functionally tested for product fit using a lab supplied trocar and was found to be non-conforming as the soft tip does not insert into the trocar and bends where the soft tip is torn.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.Photos attached to the parent file were reviewed by the manufacturing site.Three photos were attached.Photo 1 shows cannula on top of a complaint form.Photo 2 shows an image of a complaint form.Photo 3 shows two pak labels with the lot code 16f4lx and 16p78v.Reported product and lot information is confirmed.The reported issue could not be confirmed from the photo review.The sample evaluation confirms the soft tip is torn but not detached, how and when it became torn cannot be determined; however, the torn soft tip could have contributed to the reported issue of the soft tip folded over during insertion into the trocar as confirmed during functional testing.The exact root cause for damaged soft tip that caused the fit in the trocar issue is unknown, therefore specific action with regards to this complaint cannot be taken.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: 21397545
• Report Number: 2523835-2025-00130
• Device Sequence Number: 18110645
• Product Code: HMX
• UDI-Device Identifier: 00380651495234
• UDI-Public: (01)00380651495234(17)281231(11)240112(10)16F4LX
• 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): 07/14/2025

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: 16F4LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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