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

Catalog Number ASKU

Device Problems Improper Flow or Infusion (2954); Pressure Problem (3012)

Patient Problem Muscle Hypotonia (4531)

Event Date 10/01/2020

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 surgeon reported experiencing problem with the hypotonia during an unknown number of vitrectomy procedures and the problem does not occur when the three-way stopcock was not connected or by switching off the pressure compensation intraocular control also leads to fewer pressure problems.

Manufacturer Narrative

Additional information provided in e.1.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The customer did not retain the product lot information, therefore the device history records traceable to the reported procedure pack could not be reviewed.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.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in h.10.The previous mdr was submitted under manufacturer report number 1644019-2020-00597.New product information indicated the product was associated with a different manufacturer.Any additional information will be provided under manufacturer report number 2028159-2021-00521.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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 92618
• MDR Report Key: 10795595
• MDR Text Key: 216685654
• Report Number: 1644019-2020-00597
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1