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

Catalog Number 8065752437

Device Problem Detachment of Device or Device Component (2907)

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

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 healthcare professional reported that during a vitrectomy procedure an ophthalmic needle came off from the tube while injecting the silicone oil.The surgeon re-inserted the needle and completed the procedure.This report refers to past event.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Based on information received following submission of the initial report, this event does not meet criteria for reporting as a (serious injury / device malfunction / incident) this is not reportable as it appears the customer was using this product improperly.Warnings section stipulates it should not be used for silicone oil injection.

Manufacturer Narrative

Additional information provided in h.2 and h.10.D.3.Product manufacturing site updated due to receipt of product information.G.9.Manufacturer report number corrected and reported under mdr# 2209385 for mfg 1644019-2023-00341.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that during a vitrectomy procedure an ophthalmic needle came off from the tube while injecting the silicone oil.The surgeon re-inserted the needle and completed the procedure.This report refers to past event.

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PACK
• 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: 16120841
• MDR Text Key: 307802452
• Report Number: 2523835-2023-00016
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524372
• UDI-Public: 00380657524372
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 8065752437
• Device Lot Number: 2536786H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 03/15/2023; 04/12/2023
• Supplement Dates FDA Received: 04/10/2023; 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PACK.