MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION VISION SYSTEM, ACCESSORY, IRRIGATION/ASPIRATION TUBING SET; UNIT, PHACOFRAGMENTATION

Catalog Number	8065750918
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that the tube was not connected with the handpiece tightly during the vitrectomy surgery.The product was replaced and the surgery was completed.There was no patient harm.
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
As a result of an internal review of the file, it was determined that the information provided for this event does not represent a reportable device malfunction.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that the tube was not connected with the handpiece tightly during the vitrectomy surgery.The product was replaced and the surgery was completed.There was no patient harm.As a result of an internal review of the file, it was determined that the information provided for this event tube could not connect with the handpiece tightly due to connector loose issue during surgery, does not represent a reportable device malfunction.

• Brand Name: CONSTELLATION VISION SYSTEM, ACCESSORY, IRRIGATION/ASPIRATION TUBING SET
• Common Device Name: UNIT, PHACOFRAGMENTATION
• 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: 16894231
• Report Number: 1644019-2023-00531
• Device Sequence Number: 20368427
• Product Code: HQC
• UDI-Device Identifier: 00380657509188
• UDI-Public: 00380657509188
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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 Expiration Date: 08/31/2023
• Device Catalogue Number: 8065750918
• Device Lot Number: 2518361H
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• 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