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	Insufficient Information (4580)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that phacoemulsification (phaco) tip broke in patient eye.Additional information requested and received that the irrigation suddenly decreased in phaco mode, then the tip was removed from the patient¿s eye and discovered that the phaco tip was broken in half just above the hub and contained in the sleeve.The event occurred during the sculpt mode of cataract [with intraocular lens (iol) implant] surgery.The surgery was completed on same day by replacing the new phaco tip.Patient was contacted with product but there was no patient harm.
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
One opened broken phacoemulsification (phaco) tip, without a wrench, in a tray was received for the report of phaco tip broke in patient eye.Phaco tip was broken in two pieces at cone to cannula transition area.Breakage is very jagged.Both pieces were the wall is thin, there are cracks on cannula.A hole in the metal below cone to cannula transition area was observed.Wall thickness is uneven.Thin walls observed on both broken parts of phaco tip.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 attached was reviewed by the manufacturing site.Photo show one broken phaco tip and one bent phaco tip.Reported issue confirmed from photo.The complaint evaluation confirms the phaco 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 known potential risk with the phaco tip from the milling process.Manufacturing controls are already in place to minimize the creation of this defect, an investigation has been initiated and is currently in progress, to further investigate the broken phaco tip.All phaco 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: 20308241
• Report Number: 1644019-2024-02178
• Device Sequence Number: 8866422
• Product Code: LRO
• UDI-Device Identifier: 00380650001337
• UDI-Public: (01)00380650001337(17)260531(11)240611(10)16VEVW
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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: 05/31/2026
• Device Catalogue Number: 8065000133
• Device Lot Number: 16VEVW
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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
• Patient Sex: Unknown