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

Catalog Number 8065751761

Device Problems Overheating of Device (1437); Vibration (1674); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2020

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.(b)(4).

Event Description

A physician reported the phacoemulsification handpiece prime/tuned perfectly but had no phaco power and got hot during sculpt, ultrasound and quad mode.The handpiece did make the phaco sound but the needle was not vibrating.Additional information has been received indicating the procedure was a cataract extraction procedure.The procedure was completed using an alternate phaco handpiece.There was no harm to the patient.

Manufacturer Narrative

The phaco handpiece was not returned for evaluation.The phaco handpiece manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported event could not be confirmed.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The phaco handpiece was received and a visual assessment of the returned sample found no visual nonconformities.The phaco handpiece was connected to a resistance test box, which found a measurable resistance from the high electrode to ground.The returned phaco handpiece was connected to a calibrated system.A system message (sm) [tune failed ¿ handpiece voltage low (short circuit)] displayed when the handpiece attempted tuning.Disassembling the handpiece revealed moisture ingress within the electrode chamber.The phaco handpiece was unable to tune, and thus, was not able to function in any surgical modes.Therefore, the customer reported event could not be confirmed, since phaco power and temperature were unable to be measured.Moisture ingress causing a short circuit from the high electrode to ground was observed in the electrode chamber; however, how or when moisture entered the handpiece remains inconclusive.It remains inconclusive whether or not this was related to the reported event.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• 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
• MDR Report Key: 10549804
• MDR Text Key: 208185751
• Report Number: 2028159-2020-00749
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM