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

Catalog Number 8065751908

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2018

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.(b)(4).

Event Description

An ophthalmologist reported that the trocars leak extremely and are unusable.Patient and procedure impact are unknown.The number of patients and devices involved are unknown.Additional information has been requested but not received to date.

Manufacturer Narrative

No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.No sample has been returned for evaluation for the complaint of leaky trocars; therefore, the condition of the product could not be verified.The exact root cause for this complaint is unknown, however, potential contributing factors related to the manufacturing, molding, and post cure processes of the valves has been identified.Investigations have been completed and manufacturing process enhancements are presently being implemented in order to improve the performance of the valves.Complaints are reviewed and monitored at regular intervals to evaluate effectiveness of actions taken.No additional action is required at this time.(b)(4).

Event Description

Additional information was received.The reporter informed that the trocars were exchanged and procedures were completed.The health condition of the patients involved was not affected.The reporter indicated that all of the trocars have been affected.The exact number and of patients and devices involved are unknown.

Manufacturer Narrative

Additional information provided in describe event or problem.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, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 7566154
• MDR Text Key: 110173391
• Report Number: 1644019-2018-00129
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751908
• Device Lot Number: ASKU
• Other Device ID Number: 380657519088
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM
• Patient Outcome(s): Other