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

Catalog Number 8065751763

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endophthalmitis (1835); Hypopyon (1913); Inflammation (1932); Pain (1994); Blurred Vision (2137); No Code Available (3191)

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 physician reported a patient experienced acute endophthalmitis after a surgical procedure.The patient presented with pain and blurred vision in the right eye.Conjunctival inflammation, aqueous cell, aqueous fibrin and hypopyon was noted.The patient received repeated treatment of intraocular antibiotics and frequent topical antibiotics and steroids.The patient's symptoms have completely resolved with good visual outcome.This is the second of two reports from this facility.

Manufacturer Narrative

This is a closed system.It is operated with a sterile single use consumable cassette, which is designed to isolate the patient fluid path from the console itself.Any reusable surgical instrumentation (phaco handpiece) that would come into contact with the patient would be autoclaved by the user prior to surgery, per standard industry practices and the product directions for use (dfu).The phacoemulsification (phaco) handpiece is a reusable device that must be reprocessed per the product dfu.There is no evidence that the design or performance of the system caused or contributed to this reported event of endophthalmitis.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 root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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

Event Description

Additional information has been received indicating that the surgeon does not suspect sterilization process.

• Brand Name: CENTURION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 8660001
• MDR Text Key: 146705785
• Report Number: 2028159-2019-00981
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• 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
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALCON BALANCED SALT SOLUTION; DUOVISC; ILEVRO; POVIDONE IODINE10%; VIGAMOX; ALCON BALANCED SALT SOLUTION; DUOVISC; ILEVRO; POVIDONE IODINE10%; VIGAMOX
• Patient Outcome(s): Required Intervention