MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION ULTRAVIT PROBE; VITRECTOMY, INSTRUMENT CUTTER

Catalog Number	8065751020
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
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 customer reported that the probe could not cut during surgery.The procedure type was unknown.There was no information about patient harm.
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information was provided; therefore, the root cause for the customer complaint issue cannot be determined.The cause of the reported event cannot be determined with the information obtained; 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 further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION ULTRAVIT PROBE
• Common Device Name: VITRECTOMY, INSTRUMENT CUTTER
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20618434
• Report Number: 1644019-2024-02594
• Device Sequence Number: 18030612
• Product Code: LRO
• UDI-Device Identifier: 00380657510207
• UDI-Public: 00380657510207
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K093305
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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: 8065751020
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 01/12/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 02/04/2025
• 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