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

Catalog Number 8065752914

Device Problems Energy Output Problem (1431); Appropriate Term/Code Not Available (3191); Excessive Heating (4030)

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

Event Date 02/01/2022

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 during cataract procedure an ophthalmic handpiece became hot and ultrasound failed and only irrigation aspiration (ia) was possible without any problem with mounted tip and sleeve after priming test.The procedure repeated after irrigation aspiration (ia) but the console showed error message.There was patient contact but no patient impact.Additional information has been received indicating that the procedure was completed with an alternate handpiece.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The phacoemulsification (phaco) handpiece was received and a visual assessment of the returned sample revealed no visual nonconformity.The returned phaco handpiece sample was connected to a calibrated vision system.The phaco handpiece tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.During the burn-in test, the temperature of the phaco handpiece was measured and was found to be within specifications.The phaco handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements and found the phaco handpiece to meet product specifications.A phaco handpiece 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.The phaco handpiece was found to meet specifications; therefore, the root cause of the reported event is inconclusive.Manufacturer 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 VISION SYSTEM, ACCESSORY, ACTIVE SENTRY 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: 13584469
• MDR Text Key: 285997769
• Report Number: 2028159-2022-00235
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657529148
• UDI-Public: 00380657529148
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161794
• 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,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065752914
• Device Lot Number: 140UM9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1