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

Catalog Number	8065000138
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
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 non healthcare professional reported that the phacoemulsification needle broke off during cataract surgery.The procedure was completed by replacing the phacoemulsification tip with new one.There was no patient harm.
Additional Manufacturer Narrative
Additional information provided in d.9, h.3, h.6, and h.11.One opened phacoemulsification tip and tip wrench in a small parts tray (smpt) was received for the report.Sample was visually inspected and found to be nonconforming.Phacoemulsification tip was observed to be broken at aspiration bypass (ab) hole; breakage is very jagged.Wall thickness is even.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 photos attached to the file were reviewed by the manufacturing site.Photo show a broken phacoemulsification tip and a wrench.Another photo shows a label with reported lot number.Reported issue confirmed from photo.The complaint evaluation confirms the phacoemulsification tip was broken.The root cause for the broken phacoemulsification tip cannot be determined from this evaluation.The phacoemulsification tip visual inspections do not show any manufacturing issues that would cause the broken phacoemulsification tip.The exact root cause for the broken phacoemulsification tip is unknown.Therefore, specific action with regards to this complaint cannot be taken.All phacoemulsification tips are 100% visually inspected by trained operators using thirty times magnification during the manufacturing process.Any nonconformance, such as the broken phacoemulsification tip exhibited on the returned opened sample, are removed from the lot, and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.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: 20209279
• Report Number: 1644019-2024-02083
• Device Sequence Number: 7801370
• Product Code: LRO
• UDI-Device Identifier: 00380650001382
• UDI-Public: (01)00380650001382(17)260430(11)240530(10)16U472
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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: 04/30/2026
• Device Catalogue Number: 8065000138
• Device Lot Number: 16U472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 11/17/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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