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

Catalog Number 8065752450

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 09/13/2022

Event Type  malfunction  

Event Description

A physician reported while pulling out the cutter from the eye, the trocar came out with the cutter.Upon re-inserting the trocar and attempting to insert the cutter, it was noticed that the tip of the cutter was missing.The tip of cutter was found on the table.No foreign material was observed in the eye at this time during cataract/vitrectomy combination procedure.The outer cylinder of the cutter was on the table, but the doctor was concerned about the inner cutter.There was no patient harm reported.

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).

Manufacturer Narrative

Additional information provided in d.9., h.3., h.6.And h.10.One opened probe was received, with a tip protector, in a tray.The sample was visually inspected and found to be nonconforming with the probe needle broken at the port and orange/brownish foreign material on the remaining are of the port.No functional testing with ring gage could be performed due to needle port broken condition.The probe was disassembled and the components inspected.Nominal wear observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Wear marks observed at one location on the inner cutter.A review of the device history record traceable to the lot number obtained from the device¿s radio frequency identification (rfid) tag, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The complaint evaluation was unable to confirm the report product fit issue due to the needle port broken condition, which could be a contributing factor of the trocar coming out with the cutter at the time the event was reported.The complaint evaluation confirms the probe port tip was broken.The exact root cause of the broken tip cannot be determined from this evaluation.An internal investigation has been completed and action has been implemented to reduce the frequency of broken tips.No additional actions has have been taken by the manufacturing as the reported product fit issue was unable to be confirmed.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.All assembled probe needle diameters are also 100% tested for fit into a ring gauge to insure the probe needle does not exceed a trocar opening.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.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: 15579533
• MDR Text Key: 303645199
• Report Number: 1644019-2022-00813
• 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
• Report Date: 01/06/2023

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: 8065752450
• Device Lot Number: 2535223H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM