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

Catalog Number 8065751763

Device Problem Unstable (1667)

Patient Problem Capsular Bag Tear (2639)

Event Date 09/01/2016

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 customer reported that during surgery, anterior chamber instability was observed during ultrasound.During irrigation/aspiration (i/a), the patient experienced a posterior capsule tear.The intraocular lens implant was changed from the original to another one for an extracapsular fixing and implanted into the eye.There was no vitreous prolapse.The case was completed without further incident.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received indicated the event occurred in the left eye.The patient is delighted to have clear visibility the following day of surgery.The surgeon indicated it was likely that the posterior capsule rupture may have occurred at the end of the ultrasound portion of the case.

Manufacturer Narrative

Additional information provided in device available for evaluation?, device evaluated by mfr?, evaluation codes, and additional mfr narrative.A company clinical analyst reviewed this case and stated the following: ¿the customer reported the anterior chamber is unstable.The surgeon provided additional information.The questionnaire was returned and reviewed.This is a female patient; her age is listed as unknown.The scheduled procedure was in the left eye (os).¿the patient was the fourth of four patients scheduled for surgery on (b)(6) 2016.The posterior capsule rupture occurred during irrigation/aspiration (i/a), intraocular lens implant (iol) was changed from original to another one for an extracapsular fixing and it was implanted in the eye.Since vitreous prolapse was not occurred, surgery was completed.No advisory message displayed.The event took approximately 2 minutes and 30 seconds.There were no issues priming the equipment.The surgeon alleges the event to have been caused because of the equipment.¿ the surgeon also adds: ¿the posterior capsule (pc) rupture was recognized when (i/a) was performed, therefore i believed that this event occurred during i/a.The timing was at the end of u/s, (nucleus did not remain) doctor thought that posterior capsule had risen, therefore posterior capsule rupture might have occurred at the time.¿ the system operator¿s manual contains instructions for proper prime and setup.The system graphical user interface also prompts the user through all of the steps required to prime and tune the phaco handpiece appropriately.The system operators manual also states the following warning(s): 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.Posterior capsule (pc) tear is a potential consequence of cataract extraction by phacoemulsification.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.In a prospective study that compared the two types of machines for phacoemulsification units there was no difference in the incidence of pc tear was noted.The type of machine used for phacoemulsification had no correlation with the incidence of posterior capsule tear.The system was found to meet specifications.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 incidence of pc tears during phacoemulsification ranges from 0.7% to 16%.Pc tears have been correlated with the learning curve, surgeon experience, individual surgical skill, and appropriate fluidics settings.¿ the system was examined and the reported event was not replicated.However, the fluidics module was replaced as a preventive measure.The system was tested and found to meet product specifications.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system was manufactured on february 29, 2016.Based on qa assessment, the product met specifications at the time of release.Posterior capsule tear is an issue that is occasionally reported with cataract surgery.However, a review of the complaint trends shows that the frequency reported is within known levels for this event.A root cause cannot be determined conclusively.(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: 5978341
• MDR Text Key: 55668002
• Report Number: 2028159-2016-04370
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 11/28/2016

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 09/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/18/2016; 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2016
• 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): Disability