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

Catalog Number 8065752451

Device Problem Break (1069)

Patient Problems Retinal Tear (2050); Vitreous Hemorrhage (2143)

Event Date 02/28/2022

Event Type  Injury  

Event Description

A physician reported the outer cylinder of the cutter was came off during peripheral vitrectomy procedure of left eye, causing retinal tears (hole in the peripheral retina) and vitreous hemorrhage.The product was replaced and the procedure was completed.No additional treatment was required.The patient current condition was recovering.

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

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

Manufacturer Narrative

One opened probe was received, with a tip protector, in a tray along with other items.The sample was visually inspected and found to be nonconforming with the probe needle/stiffener pulled out of the needle holder; the needle was not returned, and the inner cutter bent.The probe was disassembled and the components inspected.Nominal wear observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouge marks observed at the cutting edge, and several other locations along the inner cutter.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 reported product was processed and released according to the reported product¿s acceptance criteria.The complaint evaluation confirms that the 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.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 PAK
• 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: 13791075
• MDR Text Key: 287321374
• Report Number: 1644019-2022-00201
• 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,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 8065752451
• Device Lot Number: 2490480H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM.
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Female