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

Catalog Number 8065751763

Device Problems Unstable (1667); Aspiration Issue (2883)

Patient Problem Keratitis (1944)

Event Date 10/18/2016

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 healthcare professional reported that there was poor aspiration during a surgical procedure.During the surgery, the patient experienced chamber instability and the patient had keratitis.This report is for the third patient of five.

Manufacturer Narrative

The clinical analyst has reviewed this file and stated the following: ¿the customer reported chamber instability and poor aspiration during phacoemulsification and i/a (irrigation and aspiration).During viscoelastic removal, the chamber was shallowing and viscoelastic could not be removed properly.The surgeon noted he was not getting any followability and was taking more time and energy in phaco.The company sales representative was on site and adjusted the settings.The surgery was completed with the same system with lower parameters.Six out of the seven patients presented with keratitis following surgery.The surgeon completed a questionnaire and noted the patient was a (b)(6) male with surgery on the left eye (os).The surgeon noted keratitis during the next day post-operative visit.The keratitis cleared up after two weeks.The date of surgery was (b)(6) 2016.The event duration was twenty (20) minutes.The patient was not hospitalized.There were no medications or therapies in use at the time of the event.There was no unplanned medical intervention required to treat the event.There was no unplanned surgical intervention required to treat the event.No pre-existing ocular or medical conditions were stated.The system 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 was examined.The company representative did not indicate finding any issues that would be associated with the reported event.The system was tested and found to meet product specifications.The system was manufactured on september 5, 2014.Based on qa assessment, the product met specifications at the time of release.The system was found to meet specifications.Therefore, it is not suspected to have contributed to the reported events.(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
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6125948
• MDR Text Key: 60843959
• Report Number: 2028159-2016-05375
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2017

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: 8065751763
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other