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

Catalog Number	8065752203
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported aspiration failure occurred during cataract surgery.The surgery was completed after replacing the product with another one.There was no patient harm.It was unknown whether the incident happened during ultrasound (us) or irrigation/aspiration (i/a).
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
The customer did not retain the product lot information for this consumable procedure pack, therefore the device history records traceable to the reported procedure pack could not be reviewed.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.Visual inspection or functional testing could not be conducted in order to ascertain the failure mode for the consumable device.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.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.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.Based on our current tracking, there are no adverse trends for this reported complaint.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).
Additional Manufacturer Narrative
As the customer did not retain the finished goods lot number, deviation history review and lot history could not be reviewed.The returned sample was visually and functionally tested and passed testing.No anomalies were observed that would cause or contribute to the reported event.The vision system operator's manual provides the following regarding the loss of aspiration/suction issues: insufficient aspiration.Probable cause: 1.Loose blue luer fittings.2.Damaged o-ring (ultraflow irrigation/aspiration handpiece only).3.Clogged tip.4.Kinked or damaged tubing.5.Cracked blue fitting.Recommended solutions: 1.Reconnect securely 2.Inspect o-ring and replace, as necessary.3.Flush tip with sterile water or balanced salt solution sterile irrigation solution.Retest.Replace tip.Retest.4.Check tubing and/or replace fluidics management system.5.Check fitting and/or replace fluidics management system.The root cause of the customer's complaint could not be established; the returned sample met specifications.After an investigation of this complaint, it has been determined that this sample functioned per specifications; therefore, no corrective action is required at this time.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: CENTURION SURGICAL PROCEDURE PAK
• 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: 16866558
• Report Number: 1644019-2023-00509
• Device Sequence Number: 5385845
• Product Code: LRO
• UDI-Device Identifier: 00380657522033
• UDI-Public: 00380657522033
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065752203
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 09/21/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 08/04/2023; 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown