MAUDE Adverse Event Report: Alcon Research, LLC - Alcon Precision Device Alcon Microsurgical Instruments, Cannula Ophthalmic; Cannula, Ophthalmic

Catalog Number	8065149530
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that, during the vitrectomy procedure, the ophthalmic tip had an issue with a flute instrument that could not be inserted through the trocar as intended.The procedure was completed using an alternative flute instrument.There was no patient injury.
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).

• 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 ; +1(800)757-9780
• MDR Report Key: 50798810
• Report Number: 2523835-2026-00935
• Device Sequence Number: 15616480
• Product Code: HMX
• UDI-Device Identifier: 00380651495302
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 09/17/2026

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: 8065149530
• Device Lot Number: 17J7N3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 07/09/2025
• 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