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

Catalog Number 8065751763

Device Problems Occlusion Within Device (1423); Aspiration Issue (2883)

Patient Problem Intraocular Pressure Increased (1937)

Event Date 04/17/2018

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.(b)(4).

Event Description

A healthcare professional reported that there was low aspiration and occlusion during the phacoemulsification phase of a cataract with intraocular lens procedure.The surgery was completed.The patient presented with a spike in intraocular pressure at the day 1 postop visit.This report is 2 of 2 reports from this facility.

Manufacturer Narrative

The surgeon reported that there was low aspiration and occlusion during the phacoemulsification phase of a cataract with intraocular lens (iol) procedure.The surgery was completed.The patient presented with a spike in intraocular pressure (iop) at the day 1 postop visit.The patient has a history of advanced glaucoma.The surgeon noted a monocular complex cataract as the first case of the morning.The surgeon started phaco and noticed that there was occlusion at the phaco tip and aspiration was not working.The surgeon was pressing the footswitch with full pedal force, but the aspiration was not building beyond 2-3 out of a maximum of 34.The technician flushed the phaco handpiece and subsequently changed the tubing, the handpiece, and the cassette.The same issue persisted.The surgery was delayed almost 45 minutes.The system was rebooted and the issue resolved.The operator¿s manual contains instructions for proper prime and setup.The graphical user interface also prompts the user through all of the steps required to prime and tune the phaco handpiece appropriately.The operators manual also states the following warning(s): adjusting aspiration rates or vacuum limits above the preset values, or lowering the iop or iv pole below the preset values, may cause chamber shallowing or collapse which may result in patient injury.Ensure that appropriate system parameters and system settings are selected prior to starting the procedure.Parameter and system settings include, but are not limited to, ultrasound mode, ultrasound power, vacuum, aspiration flow rate, bottle height, iop, etc.If stream of fluid is weak or absent while filling test chamber, good fluidics response will be jeopardized.Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye.Ensure that the tubings are not occluded during any phase of operation.If the handpiece test chamber is collapsed after tuning, there is a potential of low irrigation flow through the handpiece and may result in a fluidic imbalance.This, in turn, may cause a shallowing or collapsing of the anterior chamber.Good clinical practice dictates testing for adequate irrigation, aspiration flow, reflux, and operation as applicable for each handpiece prior to entering eye.There is no evidence that the design or manufacturing of the system contributed to the reported event.The system 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 phaco 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.With no additional, related information provided, the customer reported event could not be confirmed.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, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7481075
• MDR Text Key: 107317811
• Report Number: 2028159-2018-00911
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Device Lot Number: ASKU
• Other Device ID Number: 380657517633
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEALON GV; PHACO HANDPIECE
• Patient Outcome(s): Other