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

Catalog Number 8065751763

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Edema (1820)

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

Event Description

A surgeon reported that a patient presented on post operative day with edema at the incision site, choroidal detachment and an intraocular pressure of 3mmhg.This is one of two vigilance reports being filed for this facility.Additional information has been requested but not received.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received indicted that the patient's symptoms have recovered.

Manufacturer Narrative

(b)(4).

Event Description

Additional information has been received from surgeon indicating the surgery had been relatively more difficult due to capsular pseudo-exfoliation.In the postoperative period, there was no seidel which could have explained hypotonia leading to choroidal detachment.The choroidal detachment was noted next to the incision and was trilobed with an upper and lower zone.This choroidal detachment was spontaneously regressive in a few weeks.The system is suspected because there was a choroidal detachment next to the incision, there could have been a warm-up of the edge of the incision which is transmitted posteriorly and which could be responsible for the choroidal detachment.The patient's visual acuity remains the same.The surgeon settings used are unknown.

Manufacturer Narrative

A surgeon reported that a patient presented on post-operative day with edema at the incision site, choroidal detachment, and an intraocular pressure of 3mmhg.The company sales representative spoke to the surgeon.The surgeon noted edema at the incision very frequently and the surgeon wondered if she was causing it.The company sales representative explained that the tip should stay in superficial and not deeply in the eye.Additional information was requested but not received.The operator¿s manual includes instructions for proper set up for the phaco handpiece: hold handpiece with tip pointed down into test chamber and activate fill on the setup screen.While observing stream of fluid from irrigation and aspiration ports, fill test chamber completely and slide it over end of handpiece.Ensure no air bubbles are present in test chamber.Press handpiece into instrument tray pouch with tip pointed up, and secure irrigation/ aspiration lines to clips on top of tray.Ensure tubing is not kinked.The operator¿s manual also includes the warning: if stream of fluid is weak or absent, good fluidics response will be jeopardized.Good clinical practice dictates testing for adequate irrigation, aspiration flow, reflux, and operation as applicable for each handpiece prior to entering eye.Use of appropriate technique and settings is important to minimize fragments and turbulence.If stream of fluid is weak or absent, good fluidics response will be jeopardized.Suprachoroidal hemorrhage (expulsive) during cataract surgery is one of the most devastating complications for both the surgeon and the patient.This complication is thought to be caused by sudden surgical decompression resulting in transient hypotony, which increases choroidal transmural venous pressure followed by serous effusion within the suprachoroidal space.As this accumulates, the short and long posterior ciliary vessels that traverse the suprachoroidal space become stretched.A suprachoroidal hemorrhage occurs when these vessels rupture from excessive stretching.Unlike other complications, the surgeon is generally caught unaware and unprepared.It can occur during any kind of intraocular surgery, from phacoemulsification to vitreoretinal surgery, but certain surgeries are more predisposed to developing an expulsive hemorrhage, such as intracapsular cataract extraction and open-sky procedures including penetrating keratoplasty.Expulsive hemorrhage is more commonly seen in elderly patients with generalized arteriosclerosis or hypertension.Patients with a history of expulsive hemorrhage are at higher risk of developing an expulsive hemorrhage in the other eye as well.Local ocular conditions that predispose to an expulsive hemorrhage include glaucoma, increased iop, low scleral rigidity and high myopia.Other intraoperative factors that can be important include sudden rise in blood pressure, a positive valsalva maneuver such as coughing, straining, and squeezing of the lids by the patient, a tight lid speculum causing pressure on the globe or vitreous loss during surgery.Bleeding generally starts from one of the short posterior ciliary arteries.The vessels are especially prone to rupture if they are also necrotic secondary to glaucoma or arteriosclerosis.Events might also begin with a serous choroidal detachment that leads to a sudden stretching of the ciliary vessels, leading to their rupture.Expulsive hemorrhage is recognized intraoperatively as a shallowing of the anterior chamber, spontaneous expulsion of the lens or iol, progressive vitreous loss, wound gape, a dark, expanding choroidal mass along with hemorrhage through the wound and finally the appearance of the retina and choroid in the wound.With a closed globe or in eyes with self-sealing incisions, such as in phacoemulsification, an expulsive hemorrhage is recognized as shallowing of the chamber and progressive firmness of the globe.The final prognosis depends on the time of hemorrhage, the size of the vessel involved and speedy therapy.Rapid recognition and institution of appropriate measures can help save an otherwise unsalvageable eye.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 operator¿s manual provides instructions for proper handpiece set up as well as a warning for poor fluidics response if fluid is weak or absent.With no additional, related information provided, the customer reported event was not able to 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
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7199805
• MDR Text Key: 97530075
• Report Number: 2028159-2018-00136
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 05/14/2018

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
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/17/2018
• Supplement Dates Manufacturer Received: 01/22/2018; 02/16/2018; 05/02/2018
• Supplement Dates FDA Received: 02/15/2018; 03/14/2018; 05/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2014
• 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