MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065752452

Device Problem Air/Gas in Device (4062)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2021

Event Type  malfunction  

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 Description

A customer reported that air bubbles went through the infusion line into the patients eye during a procedure and pressure was unstable.The product was replaced and the procedure was completed.There is no known patient harm.

Manufacturer Narrative

A review of the device history record traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.It was reported, that bubbles passed through infusion of the eye.And pressure was unstable.A sample was not received to date, for this complaint report.Therefore, visual inspection or functional testing could not be conducted.Without a sample, it cannot be determined, if there were any physical anomalies that led to the customer's experience.The root cause of the customer's complaint could not be established, as a sample has not been received.Without a sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship if any, of the device to the reported incident cannot be determined.No action will be taken for this occurrence, as the root cause is unknown.And a sample was not returned.Quality assurance will continue to monitor customer complaints via the complaint review meetings.And will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11804488
• MDR Text Key: 250260332
• Report Number: 1644019-2021-00320
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524525
• UDI-Public: 00380657524525
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 8065752452
• Device Lot Number: 2397052H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1