MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER ACCURUS SURGICAL SYSTEM PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065803650
Medical Device Problem Codes	Failure to Prime (1492); Suction Failure (4039)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that an ophthalmic operating console presented no aspiration during a vitrectomy procedure.The vitrectomy probe was changed but the console did not prime.The console restarted and it did not prime again.The surgery was completed after replacing the console with another one.There was a slight delay in the procedure time.The patient experienced suprachoroidal hemorrhage as the result of the delay.The patient's symptoms are resolving.Additional information has been received clarifying that the scheduled procedure was "phaco cataract extraction and intraocular lens implant" surgery.The patient was transferred to neighbor facility and underwent vitreo-retinal procedure for the suprachoroidal hemorrhage.The patient is making a promising initial recovery.This is second of two reports for this reported event.
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).
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation for the report of there was no aspiration and the probe would not prime; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined.The cause of the reported event cannot be determined with the information obtained, therefore, specific action with regards to this complaint cannot be taken.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACCURUS SURGICAL SYSTEM PROCEDURE PAK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13200829
• Report Number: 2028159-2022-00027
• Device Sequence Number: 1533594
• Product Code: LRO
• UDI-Device Identifier: 00380658036508
• UDI-Public: 00380658036508
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 8065803650
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 03/27/2022
• Initial Report FDA Received Date: 01/08/2022
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INFINITI VISION SYSTEM.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown