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

Catalog Number	8065752087
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A customer reported that the cassette was leaking and partially clogged during the cataract surgery.The surgery was completed after replacing the product.There was no harm to the patient.
Additional Manufacturer Narrative
A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A used fluidics management system (fms) was visually inspected.Surgical residue was observed in the cassette reservoir and the drain bag.The drain bag was easily detached from the cassette cover due to saturation.An air pocket was observed on the left drain port between the drain bag tape and the cassette cover.The sample was tested using a console.The fms primed and tuned with the handpiece, the 0.9-millimeter (mm) aspiration bypass system (abs) tip and infusion sleeve from lab stock successfully.Cassette max vacuum and aspiration flow rate, and irrigation flow rate were measured and met specifications.Procedure indicates that during the manufacturing process, the assembler is to "place the drainage bag on the designated area of the fms per the drawing.Ensure that the three holes on the drainage bag are properly aligned with the three drainage ports." additionally, they are to "ensure no air pockets are visible around the drain bag port." no clog or leaks were found; however, the root cause of the leakage report is likely related to operators not applying the drain bag as described in the procedure.The air pocket found on the drain bag tape can lead to leaking.Action will not be taken for this occurrence.Based on our current tracking, there are no adverse trends for this reported complaint.Complaints are continuously monitored to identify product and/or process areas where events like this one are occurring.In addition, routine training and awareness is conducted with all manufacturing associates to reinforce the importance of inspecting components and preventing assembly errors on the product.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: INFINITI 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: 16833851
• Report Number: 1644019-2023-00490
• Device Sequence Number: 16608189
• Product Code: LRO
• UDI-Device Identifier: 00380657520879
• UDI-Public: 00380657520879
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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 Expiration Date: 10/31/2024
• Device Catalogue Number: 8065752087
• Device Lot Number: 156D84
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2022
• 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 Age: 78 YR
• Patient Sex: Female