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

Catalog Number 8065751763

Device Problems Unstable (1667); Device Handling Problem (3265)

Patient Problem No Code Available (3191)

Event Date 05/13/2016

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 addition reportable information becomes available.(b)(4).

Event Description

A surgeon reported a patient experienced instability of eye chamber during a cataract extraction with intraocular lens implantation.The case was completed after performing an anterior vitrectomy.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.Patient was sent to a retinologist at another facility.This is one of three reports being filed for the same facility.Additional information has been requested but none received to date.

Manufacturer Narrative

The surgeon reported that on three (3) 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.This case was completed after performing an anterior vitrectomy.The patient was sent to a retina specialist at another facility.Additional information received from company sales representative noted he observed surgery with the surgeon.The surgeon completed seven (7) cataract surgeries, which went perfectly.The surgeon is completely satisfied with the system, and by the i/a in particular.The surgeon used the new 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.The company sales representative tested the circuit and the system's vacuum was increasing correctly upon tip obstruction.No abnormality was detected.No system message displayed.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.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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 5704366
• MDR Text Key: 46764358
• Report Number: 2028159-2016-02392
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2016

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
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2016
• Initial Date FDA Received: 06/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2015
• 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): Required Intervention