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

Catalog Number	8065751014
Medical Device Problem Code	Radiofrequency Interference (RFI) (2314)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Additional 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A customer reported that during surgery, the auto gas filed device was ejected from ophthalmic system with sufficient force to impact the surgical technician standing infront of the system.The technician had mild to moderate sore for few days due to the impact of gas expulse from the system.The procedure was completed.There was no patient impact and procedure details were not reported.
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.The product lot information for this consumable procedure pack is unknown, therefore the device history records traceable to the reported procedure pack could not be reviewed.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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A customer reported that during surgery, the auto gas filed device was ejected from ophthalmic system with sufficient force to impact the surgical technician standing infront of the system.The technician had mild to moderate sore for few days due to the impact of gas expulse from the system.The procedure was completed.There was no patient impact and procedure details were not reported.This file pertains to the pack.

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK, AUTO GAS FILL
• Common Device Name: 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: 19936108
• Report Number: 1644019-2024-01784
• Device Sequence Number: 4875798
• Product Code: LRO
• UDI-Device Identifier: 00380657510146
• UDI-Public: 00380657510146
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065751014
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 11/06/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION VISION SYSTEM.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown