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

Catalog Number 8065751763

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 05/13/2016

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 surgeon reported that there were two cases of instability of eye chamber during a cataract extraction with intraocular lens implantation.The cases were completed with no harm to the patients.It was noted that this was the surgeon's first time performing nano incisions of 2.0mm and the first cataract surgeries with this system.Additional information has been requested but not received to date.This is one of three reports being filed for the same facility.This report is for two patients with instability of chambers.The alcon reference numbers are: (b)(4).

Manufacturer Narrative

The clinical analyst has reviewed this file and stated the following: ¿the surgeon reported that on (b)(4) surgeries performed that day, the surgeon experienced instability of chambers repeatedly.It is noted that the surgeon was starting at the same time the practice of nano incisions in 2.0mm.The company sales representative noted this practice favors the compression of the sleeve.The case was completed with no harm to the patient.Additional information received from company sales representative noted he observed surgery with the surgeon.The surgeon completed (b)(4) cataract surgeries, which went perfectly.The surgeon is completely satisfied with the system, and by the irrigation/aspiration (i/a) in particular.The surgeon used the new ultraflow i/a handpiece versus the old model last time.The surgeon stayed in 2.0 mm and he did not particularly change his technique of the incision, except for the positioning of the sleeve on the tip which he pushed a bit more.The company service representative adjusted the settings to the surgeon¿s satisfaction.Intraocular surgery has always been recognized to induce substantial intra-ocular pressure (iop) fluctuations, this is true for both anterior (i.E.Cataract surgery) and posterior segment (i.E.Vitrectomy) surgeries.Acute ocular hypotony is common during many intraocular surgeries.Intra-operatively, maintenance of eye pressure is a balance between infusion (irrigation) and extrusion (aspiration) with both parameters actively controlled by the surgeon and with the advent of iop control features, supported by vitrectomy/phaco machines.Hypotony (<5mmhg) is in fact fairly common in eye surgery that most eye surgeons anticipate this to occur during surgery.Surgeons have been trained to recognize and mitigate this by adjustment of the previously mentioned parameters be it manually or through the machine to adapt to what is being performed during surgery.As stated in the system operators manual: ¿the closed loop system that adjusts iop cannot replace the standard of care in judging iop intraoperatively.The surgeon must continue the common practice of informally judging the following: finger palpation on the globe, tactile feedback of the surgical instruments, retinal vessel perfusion/pulsations, and presence of corneal edema.If the surgeon believes the iop is not responding to the system settings and is dangerously high, the surgeon can do one or more of the following as they deem appropriate in this situation (with care to avoid sudden hypotony): close the infusion stopcock, pinch the infusion line, remove the infusion line.¿ the company sales representative tested the circuit and the system's vacuum was increasing correctly upon tip obstruction.No abnormality was detected.There is no information to suggest the system had any nonconformity or that it caused the reported event.The system was manufactured on september 10, 2015.Based on qa assessment, the product met specifications at the time of release.The 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5707509
• MDR Text Key: 48035152
• Report Number: 2028159-2016-02423
• 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: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Other Device ID Number: 2.04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2016
• Initial Date FDA Received: 06/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other