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

Catalog Number 8065750958

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2019

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 during surgery the tip broke in half.Both fragments were retrieved from the eye.There was no patient harm.The patient will be monitored.

Manufacturer Narrative

A review of the device history records traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there were no additional complaints associated with the lot for the reported issue.One opened fragmentation tip was returned for evaluation for the report of the tip breaking during surgery.A visual inspection of the tip was performed and deemed nonconforming.The tip is broken at the middle of the cannula.The break region is slightly jagged.The wall thickness at the break area is even.No visual occlusion in the inside diameter.The bevel edge show wear.Wear is also present on the flange and threads from being on a handpiece.No specific action with regard to this complaint was taken by the manufacturing facility because the reason for the complaint issue cannot be determined.All tips are 100% visually inspected by trained operators using magnification during the manufacturing process.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The complaint evaluation does confirm the tip is broken.The root cause for the broken tip cannot be determined from this evaluation.The visual inspection does not show any manufacturing issue that would cause the broken tip.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION FRAGMENTATION PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 8413391
• MDR Text Key: 138910518
• Report Number: 1644019-2019-00031
• 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: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 8065750958
• Device Lot Number: 2163278H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Date Manufacturer Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1