MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; 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 Date 02/17/2021

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 cutter tip came off and fell in the eye during a procedure.It was removed from the eye.There was no patient harm.

Manufacturer Narrative

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

Event Description

Additional information was received, the reporter informed that a strange sound occurred three minutes after the usage, during the procedure.The probe was continuously used for as long as 20 minutes.The customer recognizes that the probe should not be used more than 20 minutes, since it could be damaged.

Manufacturer Narrative

Additional information provided in b.5.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The returned sample was visually inspected and found to be non-conforming with only the tip of the needle returned.A provided slide deck containing multiple photos was reviewed by the manufacturing site.The photos confirm the tip of the probe was broken.The product was processed and released according to the product¿s acceptance criteria.The complaint evaluation confirmed the broken tip.The entire probe sample was not returned, therefore, the exact root cause of the complaint could not be verified.An exact root cause of the complaint could not be verified, therefore, no specific action with regard to this complaint was taken.Probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.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
• MDR Report Key: 11342654
• MDR Text Key: 233827588
• Report Number: 1644019-2021-00106
• 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,Followup
• Report Date: 05/27/2021

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: 05/31/2022
• Device Catalogue Number: 8065752437
• Device Lot Number: 2389319H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 02/24/2021; 02/24/2021; 05/27/2021
• Supplement Dates FDA Received: 02/22/2021; 02/24/2021; 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM
• Patient Age: 20 YR