MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE; UNIT, PHACOFRAGMENTATION

Catalog Number 8065751761

Device Problems Failure to Deliver Energy (1211); Intermittent Energy Output (4025)

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

Event Date 02/21/2023

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 an ophthalmic phacoemulsification handpiece got tuned however during cataract surgery while performing phacoemulsification there was initial interruption in power delivery and stopped working, also displayed error code.The tip was found to be loose.The surgery was completed on the same day.There was no patient harm reported.

Manufacturer Narrative

A non-conformance based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.A visual assessment of the returned sample revealed no visual nonconformities.The returned sample was connected to a calibrated vision system.The handpiece tuned successfully and completed a five minute burn-in test with the system set at 100% ultrasonic and torsional power.Customer reported that their generated system message handpiece test failed], inconsistent power delivery and failed to work.No functional problem was found with the returned handpiece during testing at itc; therefore, the customer reported event was not able to be confirmed.The returned handpiece was found to functionally exhibit no problems; therefore, the root cause of the reported event is inconclusive.Through investigation of this complaint, it has been determined that this handpiece functionally exhibited no issues.Therefore, no corrective actions will be pursued at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis by the product team.

• Brand Name: CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16608776
• MDR Text Key: 312017187
• Report Number: 2028159-2023-00349
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657517619
• UDI-Public: 00380657517619
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 08/24/2023

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: 8065751761
• Device Lot Number: 14CAJW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1