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

Catalog Number	8065000133
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Intraocular Pressure Decreased (4468)
Date of Event	07/11/2024
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 physician reported that phacoemulsification tip was broken during cataract surgery with intraocular lens implant.The surgery was completed by replacing with new one.There was no patient harm.
Additional Manufacturer Narrative
Additional information provided in d,4., d.9., h.2., h.3., h.6.And h.11.One opened broken phacoemulsification tip without a wrench, with a sleeve in a plastic cup, in a bag was received for the report.Sample was visually inspected and found to be nonconforming.Broken a little below cone to transition area.Breakage is very jagged.Cracks in cannula on both parts where parts broke in two pieces.Wall thickness is very uneven at the break area.Wear observed on threads, back of flange, and nut corners consistent with threading on handpiece.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The photo attached to the file was reviewed by the manufacturing site.Photo show a broken phacoemulsification tip.Reported issue confirmed from photo.The complaint evaluation confirms the phacoemulsification tip is broken.The reason for breakage is due to a uneven wall thickness creating a weak region at the thinner section.The uneven wall thickness is a manufacturing issue created at the machining process for the phacoemulsification tips.An investigation has been initiated and is currently in progress, to further investigate the broken phacoemulsification tip.All phacoemulsification tips are 100% visually inspected by trained operators using 30x magnification throughout the manufacturing process.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.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: 19919157
• Report Number: 2523835-2024-01897
• Device Sequence Number: 12790620
• Product Code: LRO
• UDI-Device Identifier: 00380650001337
• UDI-Public: (01)00380650001337(17)260228(11)240326(10)16NCJ1
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 02/28/2026
• Device Catalogue Number: 8065000133
• Device Lot Number: 16NCJ1
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• 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: CEN VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HP; CUSTOM-PAK SURGICAL PROCEDURE PACK
• Patient Age: 76 YR
• Patient Sex: Female