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

Catalog Number 8065751761

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2020

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

Event Description

A customer reported that before surgery, the phaco handpiece is unable to pass the test, and a system advisory displays.The tip is tightened again, but always fails test.After testing many times, the handpiece finally passes test.However, the surgeon felt there was no energy when using it.

Manufacturer Narrative

The phaco handpiece was received and a visual assessment of the returned sample found no nonconformities.The returned phaco handpiece was connected to a calibrated cataract system.System message (sm) [tune failed ¿ loose tip] displayed when the phaco handpiece attempted tuning.Disassembling the handpiece revealed moisture ingress within the electrode chamber.The customer reported event was confirmed which found moisture ingress to cause a short circuit from the high electrode to ground.The root cause of the reported event can be attributed to moisture ingress causing a short circuit from the high electrode to ground; however, how or when moisture entered the handpiece remains inconclusive.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided h.6.And h.10.The phaco handpiece was not returned for evaluation.The phaco handpiece manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in b.5.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received reporting the handpiece was exchanged to complete surgery.There was no patient harm.

• 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: 10191960
• MDR Text Key: 196973037
• Report Number: 2028159-2020-00462
• 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,Followup
• Report Date: 10/19/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 06/24/2020
• Supplement Dates Manufacturer Received: 06/25/2020; 08/28/2020; 10/12/2020
• Supplement Dates FDA Received: 07/02/2020; 09/09/2020; 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1