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

Catalog Number 8065752201

Device Problems Break (1069); Noise, Audible (3273)

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

Event Date 02/22/2021

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 customer reported that the tip made no grove in lens and had an unusual noise during a procedure.The phacoemulsification tip end broke inside the patient¿s eye and got stuck in the incision.Same issue occurred with the second phacoemulsification tip.The complete pak was replaced and procedure completed with no patient harm.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of the tip made no groove or noise and the tip broke during incision; therefore, the condition of the product could not be verified.The product was processed and released according to the product¿s acceptance criteria.The photo attached to the parent complaint was reviewed by the manufacturing site.The photo is of a pak label, the reported product and lot information is confirmed.A sample was not received at the manufacturing site and the product was released to the product¿s acceptable criteria; therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown; therefore, specific action with regards to this complaint cannot be taken.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

One opened broken phacoemulsification tip in a vial was received for the report of the tip made no groove or noise and the tip broke during incision.The phacoemulsification tip was visually inspected and deemed nonconforming, the phacoemulsification tip was broken at the air bypass (ab) hole with a jagged edge with even wall thickness.There was wear on the threads consistent with use.There was white foreign material along the tip that is consistent with surgical material.A functional thread check was performed with a go/no-go 4-40 thread gage and the threads were found to be conforming.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The photo attached to the parent complaint was reviewed by the manufacturing site.The photo is of a pak label, the reported product and lot information is confirmed.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 inspection does not show any manufacturing issue that would cause the broken phacoemulsification tip.The complaint evaluation does not confirm the report of the tip to handpiece interface issue.The returned sample was found to be conforming for all functional testing associated with the reported event, therefore a tip made no groove or noise as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No specific action with regard to this complaint was taken because the root cause for the complaint issue cannot be determined from this evaluation.All phacoemulsification tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Any nonconformance, such as the broken phacoemulsification tip exhibited on the returned opened sample, is removed from the lot and scrapped.No action was taken on the tip made no groove or noise as the product was manufactured to specification.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
• Type of Device: 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: 11485271
• MDR Text Key: 240615418
• Report Number: 1644019-2021-00159
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657522019
• UDI-Public: 00380657522019
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 8065752201
• Device Lot Number: 2390854H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM (ACTIVE SENTRY); CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE
• Patient Sex: Female