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

Catalog Number	8065752193
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An other healthcare professional reported that there was no perforation was noticed in the sleeve during cataract intraocular lens implant surgery.The procedure and patient harm details was not reported.
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 manufacturer internal reference number is: (b)(4).
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.An image provided by the customer shows a low resolution image of a pink sleeve without the irrigation holes at the tip.The supplier manufacturing process for the infusion sleeves involve molding the sleeve, and then the final tip punch step where the irrigation holes are formed.The supplier also performs a sampling inspection after the cut and punch operation.Furthermore, it should be noted that the directions for use state that 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 of no hole and blocked aspiration is related to an error caused during the suppliers manufacturing process during the assembly of the infusion sleeve.The supplier manufacturer will be notified and made aware of this complaint issue.No further action will be taken for this occurrence.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: 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: 18533278
• Report Number: 1644019-2024-00110
• Device Sequence Number: 20502205
• Product Code: LRO
• UDI-Device Identifier: 00380657521937
• UDI-Public: 00380657521937
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2024

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: 05/31/2025
• Device Catalogue Number: 8065752193
• Device Lot Number: 15PWYK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 03/21/2024; 05/08/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 04/17/2024; 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Patient Age: 82 YR
• Patient Sex: Male