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

Catalog Number AS18511-01

Device Problem Material Twisted/Bent (2981)

Patient Problem Rupture (2208)

Event Date 04/19/2022

Event Type  Injury  

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 Description

A physician reported irrigation tube was found bent and deformed it was straightened by hand and used but the anterior chamber was unstable and had a rupture during a cataract procedure.Anterior vitrectomy probe was used to complete the procedure.The same is not available for return.Additional information received from the company representative who indicated the patient's current condition is improving.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The customer did not retain the product lot information for this procedure pack, therefore the device history records traceable to the reported procedure pack could not be reviewed.Based on our current tracking, there are no adverse trends for this reported complaint.A customer reported that an irrigation tube of the fluidics management system (fms) pak was bent and deformed.A wet fms was visually inspected.The irrigation line was bent from the cassette insertion.The fms was tested on a console.The sample primed and tuned with the ultrasonic handpiece successfully.No message code, no fluid or air leaks, and no cracks on the luers were found.The bend on the irrigation line did not affect the functionality.While the customer¿s complaint of bent tubing was confirmed, testing of the sample showed that the bend was cosmetic and did not affect the performance of the product.The cause of the bend is consistent with a defect observed when the tubing is improperly placed in the tray during the manufacturing process.Procedural enhancements will be implemented for better handling of tubing and will help mitigate and reduce recurrence of the reported issue.All lots are verified that all required inspections have been performed and all acceptance criteria are met prior to release.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
• Type of Device: 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: 14250634
• MDR Text Key: 290383890
• Report Number: 1644019-2022-00326
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AS18511-01
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other