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

Catalog Number 8065753106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Retinal Tear (2050)

Event Date 11/03/2022

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 surgeon reported small tears of the epiretinal membrane was observed at the end of the vitrectomy procedure while performing tests with the vitrector.Per surgeon, the tear was suspected to have come from the new vitrectomy probes that were too "powerful and more tractional".The patient's was treated with cryotherapy.It was also reported that surgeon's practice, made him to stay "the pedal to the metal" (he went out of the pedal stroke).Patient information was not available.Additional information was received from the ophthalmic surgeon reported that the patient required an intraoperative retinopexy, with a fluid/air exchange and then cf6/air, because the retina was starting to detach.The patient was currently on gas, and the decrease was under monitoring.The patient presented with large tears, over 2 papillary diameters, which was very unusual in the surgeon¿s retinal procedures.The sample was discarded.This complaint refers to patient 1 of 2.

Manufacturer Narrative

The lot complaint history and dhr (device history record) were not reviewed as no lot information was available for this complaint.The sample was not received at the investigating site for this complaint report; visual inspection or functional testing could not be conducted.If a sample is returned at a later date, the investigation will be reopened and the sample will be evaluated.The root cause of the customer's complaint could not be established as a sample has not been received.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.After an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and no root cause could be established.No adverse trends have been observed associated with the reported product and event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.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: 15810224
• MDR Text Key: 303793876
• Report Number: 1644019-2022-00952
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657531066
• UDI-Public: 00380657531066
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065753106
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM; CONSTELLATION VISION SYSTEM
• Patient Outcome(s): Required Intervention; Other