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

Catalog Number	8065751766
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
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 nurse reported that the aspiration was not working efficiently and advisory message for aspiration when the doctor started with the vitreous removal.The doctor requested from the nurse to replace the cassette with a new cassette.There was no patient harm.
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.Upon visual inspection the irrigation connector on the irrigation/aspiration (i/a) tubing manifold was cracked which result in a fluidics imbalance and likely contributed to the reported event.The light green port on the cassette body was found to be in good condition.The connectors were attached to the cassette port.When the sample was tested on a calibrated console fluid leakage was observed from the cracked irrigation connector.The crack was on the distal end and propagation toward the proximal end was observed.There was no stressing of the material indicated at the proximal end.The customer should be reminded the directions-for-use state good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye.The root cause of the customer's complaint could not conclusively determine when and where the crack occurred, however, the source of the complaint is likely related to the crack on the connector.After investigation of this complaint no corrective action is required at this time.Based on our current tracking, there are no adverse trends for this reported complaint and lot.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
• 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: 19223703
• Report Number: 1644019-2024-00884
• Device Sequence Number: 17868459
• Product Code: LRO
• UDI-Device Identifier: 00380657517664
• UDI-Public: (01)00380657517664(17)250930(11)231030(10)169P9A(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2024

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: 09/30/2025
• Device Catalogue Number: 8065751766
• Device Lot Number: 169P9A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 09/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown