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

Catalog Number 8065752450

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Retinal Tear (2050)

Event Date 06/17/2021

Event Type  Injury  

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 physician reported tip outer cylinder came off during surgery which resulted in hole in the retina and led to hemorrhage.The product was replaced and the surgery was completed.A retinal tear was treated with laser irradiation and surgery was completed.Patient outcome is unknown.

Manufacturer Narrative

One opened probe was received with a tip protector in a tray, along with a usb and other items.For the report of outer cylinder of cutter came off.The returned sample was visually inspected, and found to be non-conforming with the needle/stiffener assembly separated from the rest of the probe assembly.The probe sample was disassembled and the components inspected.No/minimal wear was observed, on the inner cutter when compared to the degree of wear, based on continuous actuation of the probe visual standard photos.Gouge marks were observed, at several locations along the inner cutter.The video on the received usb was reviewed by the investigation site.The needle appears to have advance forward.The reason for advancement is unknown, based on the field of view.A red appearance was then observed, in the back of the eye.It is unknown, exactly what the red appearance is.The product was processed and released according to the product¿s acceptance criteria.The evaluation confirms, the reported issue of outer cylinder of cutter came off.The root cause for the component detachment is the adhesive bond failure, which caused the needle assembly to detach from the rest of the probe assembly.An internal investigation was completed.And improvements to the adhesive bond have been identified.A photo of the returned sample has been issued within the learning management system, for review with the applicable production personnel to raise awareness of this issue.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed, for this reported event.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: 12123171
• MDR Text Key: 260239993
• Report Number: 1644019-2021-00453
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524501
• UDI-Public: 00380657524501
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 8065752450
• Device Lot Number: 2423669H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 08/09/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM; CONSTELLATION VISION SYSTEM
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR