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

Catalog Number 8065751763

Device Problems Unstable (1667); Component Missing (2306)

Patient Problem No Code Available (3191)

Event Date 08/22/2018

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 a cataract procedure, following phacoemulsification and irrigation/aspiration, the surgeon indicated he "lost the bag" and asked for a capsular tension ring.The doctor extended the incision size to accommodate the insertion of the ring.After insertion, the doctor decided to do a vitrectomy without visualizing vitreous in the anterior chamber due to bag instability.The vitrectomy was performed and a three piece intraocular lens was sutured in to the back side of the iris.

Manufacturer Narrative

Posterior capsule (pc) tear is a potential consequence of cataract extraction by predisposition to pc tear or zonular dehiscence can be influenced by many factors including, but not limited to, congenital posterior lenticonus, posterior sub capsular (psc) cataract, poor visibility secondary to patients comorbidity ie.Dense arcus, pterygium, band keratopathy, corneal scars, interstitial keratitis.Poor microscope illumination [red reflex], ergonomic obstacles, limited intraocular working space, abnormally long or short axial lengths, pseudoexfoliation, zonular laxity, poor dilation, intraoperative floppy iris syndrome (ifis), dense cataracts, asteroid hyalosis, or inadvertent patient movement.The conditions that increase the risk of pc tear during phacoemulsification include ergonomic obstacles, limited intraocular working space, poor visualization, increased nuclear size and density, weakened zonule, a radial tear in the capsulorhexis, and an inability to rotate the nucleus or epinucleus.These conditions may arise either because of the ocular anatomy, or because of surgical technique.There is no evidence contained within the reported information at this time that indicates that the design or performance of the system had any effect on the integrity of the posterior capsule.The system operator¿s manual includes a warning: ensure that appropriate system parameters and system settings are selected prior to starting the procedure.Adjusting aspiration rates or vacuum limits above the preset values, or lowering the intraocular pressure (iop) or iv pole below the preset values, may cause chamber shallowing or collapse which may result in patient injury.When filling handpiece test chamber, if stream of fluid is weak or absent, good fluidics response will be jeopardized.Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye.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.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.Avoid setting the patient above the fluid management system (fms) unless patient eye level (pel) is used.Operating with the patient above the fms without pel adjustment will result in a lower irrigation pressure than indicated on the display, and possible under-venting.Use of balanced salt solution irrigating fluid bags other than those approved by company for use in the fluidics system can result in patient injury or system damage.Use of appropriate technique and settings is important to minimize fragments and turbulence.Do not remove the fms during the surgical procedure.In the event of a system error, release footswitch to the up position.Improper handling or removal of dual irrigation handpiece tip from eye may cause draining of the fluidics system.There was no servicing requested for this event.The system was manufactured on april 29, 2015.Based on qa assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported event could not be confirmed.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, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7872349
• MDR Text Key: 120115905
• Report Number: 2028159-2018-01930
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 11/08/2018
• Supplement Dates FDA Received: 12/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention