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

Catalog Number ASKU

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Rupture (2208); Prolapse (2475)

Event Date 01/13/2020

Event Type  Injury  

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 three patient's experienced a rhexis break capsular rupture following a software update on the system.The surgeon noted that the ultrasounds were too "effective." this file represents the third of four patients.Additional information has been requested and received.A completed questionnaire was received from the surgeon.Several occlusion phases from handpiece were noted just before posterior capsule rupture in the right eye during the aspiration of quarters of a cataract extraction with intraocular lens (iol) implant surgery.This was 3+ soft subcapsular posterior axial cataract.There was vitreous prolapse and a piece of the cortex fell into the posterior chamber.An anterior vitrectomy was preformed.The case was not completed.The patient was hospitalized and will require an additional posterior vitrectomy to remove the piece of cortex from the posterior chamber and implant the iol.

Manufacturer Narrative

The company representative has reviewed the programming with the surgeon and ¿everything is ok.¿ there was no further information provided by this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.Based on the information obtained, the root cause of the reported ¿occlusion¿ cannot be determined conclusively.Posterior capsule tear is an issue that is occasionally reported with cataract surgery.However, a review of the complaint trends shows that the frequency reported is within known levels for this event.A root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 9863731
• MDR Text Key: 188218268
• Report Number: 2028159-2020-00264
• 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
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM; VISCOPHTA
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 70 YR
• Patient Weight: 70