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

Catalog Number 8065751761

Device Problem Temperature Problem (3022)

Patient Problems Corneal Edema (1791); Intraocular Pressure Increased (1937); Nausea (1970)

Event Date 11/10/2020

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.(b)(4).

Event Description

A physician reported a phacoemulsification handpiece got warm during a vitrectomy procedure.The patient returned the afternoon of the procedure with nausea and an eye pressure of 44mmhg.The following day the patient returned to the office and presented with corneal edema.The patient was given oral treatment with a diuretic and pressure lowering eye drops.He will be retuning to the office to be monitored.Additional information has been requested this is one of two reports from this facility.

Manufacturer Narrative

The previous report submitted for this event contained an error in h.1.- ¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The phaco handpieces was not returned for evaluation.With no additional, related information provided, the customer reported events could not be confirmed.The manufacturing device history record (dhr) of each of the phaco handpieces potentially used in this procedure were reviewed.Based on assessment, each product met specifications at the time of their respective release.Based on the information obtained, the root cause of the reported events cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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: 10945488
• MDR Text Key: 219493346
• Report Number: 2028159-2020-01046
• 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: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751761
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 02/18/2021; 03/03/2021; 03/05/2021
• Supplement Dates FDA Received: 03/05/2021; 03/15/2021; 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTIVISC; ARTIVISC
• Patient Outcome(s): Required Intervention