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

Catalog Number 8065751763

Device Problems Failure to Deliver Energy (1211); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2019

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 the handpiece stopped working during a procedure.An alternate handpiece was used to complete the procedure.There was no patient harm.Additional information has been requested.

Manufacturer Narrative

The phacoemulsification handpiece was not returned for evaluation.The phacoemulsification handpiece serial number (s/n) was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.The root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information has been provided: the phacoemulsification (phaco) handpiece was received and a visual assessment of the returned sample found no visual nonconformity.The returned phaco handpiece was connected to a calibrated system.The phaco handpiece tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.The phaco handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements, which found the phaco handpiece to meet all product specifications.The phaco handpiece manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The phaco handpiece was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 8429056
• MDR Text Key: 139310024
• Report Number: 2028159-2019-00439
• Device Sequence Number: 0
• Product Code: HQC
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2019
• 2 Devices were Involved in the Event: 1 2

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: 8065751763
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/18/2019
• Supplement Dates Manufacturer Received: 04/12/2019; 07/30/2019
• Supplement Dates FDA Received: 05/07/2019; 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION OZIL HANDPIECE