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

Catalog Number 8065752450

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

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 physician reported the cutter was detached from the bottom of the cutter during a vitrectomy procedure.The cutter did not fall into the patient's eye.A laser was performed.There was no report of patient harm.Additional information received from company representative who indicated the procedure was completed using another cutter.

Manufacturer Narrative

Additional information provided in b.5.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received from the company representative who indicated the laser was performed during same procedure.

Manufacturer Narrative

A product sample has been received by the manufacturer and it is awaiting evaluation.The manufacturer internal reference number is: 2021-78229.

Event Description

Additional information received from the company representative who indicated there was no patient harm.

Manufacturer Narrative

One opened probe was received, with tip protector, in a tray along with other items.The sample was visually inspected and found to be nonconforming with the port of probe facing to the side.The sample was then functionally tested for actuation, during the actuation test the probe needle/stiffener pulled out of the needle holder.No/minimal wear observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.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 complaint evaluation confirms the probe needle/stiffener was detached from the needle holder.The root cause for the component detachment is the adhesive bond failure which caused the needle assembly to detach from the rest of the probe assembly.An internal investigation was completed and improvements to the adhesive bond have been identified.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.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
• 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: 13150171
• MDR Text Key: 283137732
• Report Number: 1644019-2022-00010
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524501
• UDI-Public: 00380657524501
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/25/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 8065752450
• Device Lot Number: 2480741H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 01/05/2022; 02/15/2022; 03/13/2022
• Supplement Dates FDA Received: 01/25/2022; 02/25/2022; 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM
• Patient Outcome(s): Required Intervention