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

Catalog Number 8065752201

Device Problems Loose or Intermittent Connection (1371); Output Problem (3005); Noise, Audible (3273)

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

Event Date 08/02/2022

Event Type  malfunction  

Event Description

A physician reported that during the cataract procedure the output of the phacoemulsification (phaco) tip was weak, and an unusual sound (abnormal noise) could be heard from the tip of the tip.Therefore, a loose tip was suspected by the reporter.The phacoemulsification tip was re-tightened, re-tested and used again.However, the treatment on the nucleus could not be performed as usual and no improvement was seen.As a result the handpiece was replaced but no improvement, then the tip was replaced and the situation improved and the procedure was completed.The reporter considered the event to be caused by the phaco tip.

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.Since the product was available for evaluation 'a product sample has been received by the manufacturer and it is awaiting evaluation'.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

One opened phaco tip with wrench in a bag was received.The phaco tip was visually inspected and found to be conforming.The threads were checked with a go/no-go 4-40 thread gage and the threads were deemed to be conforming.There was wear on the threads consistent with threading on a 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 returned sample was found to be conforming, therefore a phaco tip weak output, abnormal sound and loose tip as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the phaco tip was manufactured to specification.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 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: 15360277
• MDR Text Key: 305694029
• Report Number: 1644019-2022-00723
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657522019
• UDI-Public: 00380657522019
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 8065752201
• Device Lot Number: 2433781H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2020
• 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)