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

Catalog Number ASKU

Device Problem Device Reprocessing Problem (1091)

Patient Problems Cyclitis (1799); Endophthalmitis (1835); Hypopyon (1913)

Event Date 11/12/2020

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 surgeon reported a patient presented with endophthalmitis, hypopyon and cyclitic membrane one month and 5 days following a cataract extraction surgery.Additional information has been requested and received.A company representative has visited the site.It was noted that the ophthalmic irrigating solution bag was "hit" with a syringe to inject epinephrine, then hit again to connect the tubing of the cassette, but there was no disinfection with an alcohol wipe.This step has disappeared from their practice.Sterilization processes are called into question for the system and handpieces.Additional information has been received.The surgeon is now challenging the diagnosis of endophthalmitis due to an ultrasound scan that confirmed there is no vitreous inflammation.This is one of two reports from this facility.

Manufacturer Narrative

No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 10971791
• MDR Text Key: 220408309
• Report Number: 2028159-2020-01079
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALANCED SALT SOLUTION BSS BAG; CENTURION VISION SYSTEM; BALANCED SALT SOLUTION BSS BAG; CENTURION VISION SYSTEM
• Patient Outcome(s): Other