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

Catalog Number 8065751763

Device Problem Complete Blockage (1094)

Patient Problem Burn, Thermal (2530)

Event Date 06/10/2019

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 customer reported that during cataract surgery, the system was clogging and as a result, the patient experienced a thermal burn.Additional information has been requested.

Manufacturer Narrative

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

Event Description

Additional information has been received.The customer reported the cause of the wound burn, in the left eye, was due to clogged phaco tip during sculpt phase.Sutures were required to close the wound.

Manufacturer Narrative

Additional information provided in h.6.And h.10.Corneal thermal injuries are typically related to excessive heat generated by the phaco tip due to insufficient aspiration flow, extended energy application, or combination of both.The operator¿s manual states: appropriate use of system parameters and accessories is important for successful procedures.Use of low vacuum limits, low flow rates, low bottle heights, high power settings, extended power usage, power usage during occlusion conditions (beeping tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively tight incisions, and combinations of the above actions may result in significant temperature increases at incision site and inside the eye, and lead to severe thermal eye tissue damage.Good clinical practice dictates testing for adequate irrigation, aspiration flow, reflux, and operation as applicable for each handpiece prior to entering eye.Ensure that the tubings are not occluded during any phase of operation.Use of a phaco handpiece in the absence of irrigation flow and/or in the presence of reduced or lost aspiration flow and/or sideways orientation of the phaco tips can cause excessive heating and potential thermal injury to adjacent eye tissues.Directing energy toward non-lens material, such as iris or capsule, may cause mechanical and/or thermal tissue damage.The system is designed to cool the phaco tip during use as aspirated fluid flows through the tip lumen.Overheating of the phaco tip, however, may occur due to extended application of ultrasonic energy or compromised aspiration flow through the phaco tip.Reduced fluid flow through the phaco tip may be caused by phaco tip re-use, tip clogging by nuclear material, kinked tubing, inadequate flow and vacuum settings, or obstruction by ophthalmic viscoelastic device (ovd).When the phaco tip is occluded, infusion will cease, reducing the cooling effect of the tip.Occlusion tones (intermittent beeping tones during occlusion) alert the user, indicating that the vacuum is near or at its preset limit, and aspiration flow is reduced or stopped.The surgeon must recognize the occlusion tones and manually stop the ultrasound mode in order to prevent a rapid temperature increase.A phaco tip sample was not received at the manufacturing site for evaluation for the report of thermal burn, clogging.Therefore, the condition of the product could not be verified.No lot number was identified with this complaint.Therefore, lot history and complaint history reviews could not be conducted.No further information was provided by this customer.With no additional, related information provided, the customers reported event was not confirmed.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.Corneal burn is an issue that is occasionally reported with cataract surgery.According to the pennsylvania patient safety advisory abstract: preventing corneal burns during phacoemulsification, march 2010, vol.7, no.1: 23-25, most corneal burns can be traced to issues related to surgical technique and not to malfunctioning equipment.The root cause 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: 8712920
• MDR Text Key: 148445620
• Report Number: 2028159-2019-01138
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION OZIL HP.; UNSPECIFIED TIP, TURBOSONIC ABS.; CENTURION OZIL HP
• Patient Outcome(s): Other
• Patient Age: 60 YR