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

Catalog Number 8065752451

Device Problems Failure to Cut (2587); Noise, Audible (3273)

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

Event Date 01/19/2023

Event Type  malfunction  

Event Description

A physician reported the (probably) outer cylinder side vibrated significantly shortly after a probe was inserted and activated during cataract/vitrectomy combination procedure.Since there was a risk that the opening part (aspiration port) might be wobbly and the retina might be mistakenly aspirated.The product was replaced with another one and the surgery was completed.Actuation failure was confirmed.It was unknown whether aspiration issue was occurred.There was no patient harm.

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

One opened probe was received with a tip protector, in a tray.The returned sample was visually inspected and found to be non-conforming with no adhesive observed on the needle holder at the needle holder / stiffener bond area.The sample was then functionally tested for actuation and aspiration.No vibration was observed during testing.During the actuation test, the needle/stiffener assembly pulled out of the needle holder.Cut testing was unable to be performed due to the needle/stiffener assembly pulling out of the needle holder.The probe sample 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.Gouge marks were observed at a couple locations along the inner cutter.Presence of adhesive was observed at one location on the stiffener sleeve.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 product was processed and released according to the product¿s acceptance criteria.The evaluation indicated that the needle/stiffener assembly was detached from the needle holder.The reported actuation failure was unable to be confirmed as the actuation test, as well as the cut test, was unable to be performed due to the detachment.The reported vibration was not confirmed, however, the component detachment could have caused the needle to vibrate at the time the reported event was observed.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.How and when the adhesive bond failed cannot be determined, however a manufacturing related root cause cannot be ruled out.A non-conformance investigation was initiated in order to investigate the root cause of the component detachment.No additional action was taken by the manufacturing site since the reported vibration was not confirmed and the reported actuation failure could no be confirmed.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.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PACK
• 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: 16467274
• MDR Text Key: 310511128
• Report Number: 1644019-2023-00200
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524518
• UDI-Public: 00380657524518
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 8065752451
• Device Lot Number: 14ML8A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM.