MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE LEGION ANTERIOR VITRECTOMY KIT; UNIT, PHACOFRAGMENTATION

Catalog Number	8065753056
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that probe was not cutting in the right eye during the cataract [with intraocular lens (iol) implant] surgery.The surgery was completed by replacing the probe.The product came into contact with the patient, there was no impact on the patient.
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
One opened probe was received, in a blister.The sample was visually inspected and found to be nonconforming with orange/brown foreign material on the port face.The sample was then functionally tested for actuation and cut.The sample was found to be conforming for both functional tests.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 attached photos were reviewed by the manufacturing site.Photo one shows a label with reported lot number.Photo two show a probe with other components in a blister.Reported issues cannot be confirmed from photos.The returned sample was found to be functionally conforming; therefore, probe was not cutting as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the returned probe was functionally conforming.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.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 further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: LEGION ANTERIOR VITRECTOMY KIT
• Common Device Name: UNIT, PHACOFRAGMENTATION
• 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: 21045684
• Report Number: 2523835-2024-02553
• Device Sequence Number: 19652627
• Product Code: HQC
• UDI-Device Identifier: 00380657530564
• UDI-Public: (01)00380657530564(17)270131(11)240221(10)16K7VT
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K191650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 8065753056
• Device Lot Number: 16K7VT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LEGION CART
• Patient Sex: Unknown