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

Catalog Number 8065752134

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/24/2021

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 physician reported the anterior cutter actuator¿s tube came off and the anterior cutter did not actuate while aspirating during a cataract procedure.The product was replaced with another one and the procedure was completed.There was no harm to the patient.

Manufacturer Narrative

The lot complaint history was reviewed; this is the first complaint for the finish goods lot and first for this issue for this lot.The device history record shows the product was released per specifications.A customer reported that the tube that actuates the cutter comes off.The image provided by the customer showed the rear shell detached from the engine, also the tubing was observed detached from the engine.Based on the image we are unable to ascertain how both the probe shell and tubing were both detached.The rearshell is an ergonomical feature for handling the probe and is attached to the probe engine during final assembly.The sample was not returned for this investigation for evaluation.The root cause of the customer's complaint could not be determined conclusively how or when the detachment occurred.The condition of the physical sample was unable to be verified for this investigation.After an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and no root cause could be established.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION ULTRAVIT PROBE 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 ; 8175514979
• MDR Report Key: 12509827
• MDR Text Key: 272664343
• Report Number: 1644019-2021-00577
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657521340
• UDI-Public: 00380657521340
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

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 Expiration Date: 02/28/2023
• Device Catalogue Number: 8065752134
• Device Lot Number: 2460882H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/21/2021
• Supplement Dates Manufacturer Received: 11/23/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• 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)