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

Catalog Number 8065750853

Device Problems Obstruction of Flow (2423); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2023

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 nurse reported that the tip of needle curved during cataract surgery and error message of "flow obstruction¿ was displayed when equipment was connected.The surgery was completed after replacing the product with new one.There was no patient harm reported.

Manufacturer Narrative

Four opened phaco tips in wrenches, in blisters were received for the report.All four samples were visually inspected, sample #1, #3 and #4 were found to be conforming and sample #2 was found to be nonconforming.Tip of phaco was found to be bent for sample #2.There was wear on the threads, back of flange and on nut corners that was consistent with threading on a handpiece for all samples.A functional occlusion flow check was performed and all four samples were 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 complaint evaluation confirms the phaco tip cannula is bent of sample #2.How and when the phaco tip became bent cannot be determined from this evaluation.The most likely cause of a bent phaco tip cannula is from improper handling of the product.The returned samples #1, 3 and 4 were found to be conforming for functional testing associated with the report of flow obstruction; therefore, a report of error message of flow obstruction was not confirmed and a root cause cannot be determined for the complaint as described by the customer.Sample 1, 3, and 4 were found conforming and sample 2 no specification action was taken with regard to this complaint was taken because the root cause for the complaint issue 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 phaco tip cannula bent 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: 17622939
• MDR Text Key: 321935593
• Report Number: 2523835-2023-00439
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657508532
• UDI-Public: 00380657508532
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

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: 15AY6M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 10/28/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1