MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE CENTURION VISION SYSTEM, HANDPIECE TIP; UNIT, PHACOFRAGMENTATION

Catalog Number 8065750853

Device Problems Break (1069); Blocked Connection (2888)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2023

Event Type  malfunction  

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 Description

A physician reported that the tip was broken and the handpiece did not aspirate and irrigate correctly at an unknown timing.The procedure was completed after the tip was changed.The patient harm details was not reported.

Manufacturer Narrative

One opened phaco tip in a wrench / in a plastic bag was received for the report.Sample was visually inspected and found to be conforming for occlusion and nonconforming for broken/cracked tip.Phaco tip appears to be broken at the bevel.The break appears to be straight going up the cannula.Wall thickness is even.Wear observed on threads, back of flange, and nut corners consistent with threading on handpiece.A occlusion flow test was performed and found to be conforming.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 were reviewed by the manufacturing site.The photos show a phaco tip with cracked cannula.The reported cracked tip complaint can be confirmed from photo.The complaint evaluation confirms the phaco tips were broken.The root cause for the broken phaco tips cannot be determined from this evaluation.The phaco tip visual inspections do not show any manufacturing issues that would cause the broken phaco tips.The complaint evaluation does not confirm an occlusion, therefore the root cause cannot be determined from this evaluation.The most likely root cause for the report of occlusion (did not aspirate and irrigate correctly) is the cracked phaco tip.The tip was found conforming for occlusion and the exact root cause for the cracked tip cannot be determined from this evaluation.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Any nonconformance, such as the cracked phaco tip exhibited on the returned opened sample, is 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 VISION SYSTEM, HANDPIECE TIP
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17782042
• MDR Text Key: 323848551
• Report Number: 2523835-2023-00476
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657508532
• UDI-Public: 00380657508532
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: K121555
• 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: 01/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 8065750853
• Device Lot Number: 1507DK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 01/07/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1