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

Catalog Number 8065752200

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2023

Event Type  malfunction  

Event Description

A physician reported that there was a drain bag connection on the cassette was peeling off and the waste fluid leaked during cataract surgery intraocular lens implant additionally the tip of the sleeve was found torn.The surgery was completed after the product was replaced with another one.There was no patient harm.

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).

Manufacturer Narrative

Additional information provided in d.9., h.3., h.6.And h.10.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.One used sleeve was received with the sample.The sleeve was inspected and confirmed that the port of the sleeve was torn.Refer to qs 2200285 for the report of the drain bag.Based on the analysis of the returned sample, the customer's event is related to customer handling during the surgical set up process.Improper mounting of the infusion sleeve on the handpiece can cause a tear (or entire shaft removal) on the infusion sleeve, leading to the customer's reported experience.After an investigation of this complaint, it has been determined that no action will be taken at this time; however, user handling is suspected.Based on our current tracking, there are no adverse trends for this reported complaint.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION 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: 16713444
• MDR Text Key: 313029186
• Report Number: 1644019-2023-00395
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657522002
• UDI-Public: 00380657522002
• 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
• Report Date: 08/24/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2024
• Device Catalogue Number: 8065752200
• Device Lot Number: 14XPAV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 07/28/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM (ACTIVE SENTRY)