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

Catalog Number 8065752450

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2020

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 customer reported that the tip of the cuter was found to be gone during a procedure.The patient's eye was checked and the tip could not be located.The product was replaced and the procedure was completed.There was no patient harm.

Manufacturer Narrative

The returned sample was visually inspected and found non-conforming with the probe needle broken at the port and the probe needle was also bent.The probe was disassembled and the components inspected.Nominal wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.The inner cutter was observed to be severely bent.Wear marks were observed at one area along the inner cutter and gouge marks were observed at the cutting edge of the inner cutter.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The complaint evaluation confirmed that the probe had a broken tip at the port and also indicated that the probe needle was bent.The exact root cause for the broken tip and bent needle cannot be determined from this evaluation.The most likely root cause for the bent needle is handling at any point after the probe was shipped from the manufacturing site, including use during surgery.An internal investigation has been completed to further evaluate the cause of probe tip breakage at the port.No additional action was taken by the manufacturing site since the exact root cause of the bent needle could not be determined.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints will continue to be reviewed and closely 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
• MDR Report Key: 9853589
• MDR Text Key: 186285377
• Report Number: 1644019-2020-00158
• 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
• Report Date: 06/18/2020

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: 09/30/2021
• Device Catalogue Number: 8065752450
• Device Lot Number: 2325908H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 05/29/2020
• Supplement Dates FDA Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM