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

Catalog Number 8065751763

Device Problem Inability to Irrigate (1337)

Patient Problems Corneal Clouding/Hazing (1878); Eye Burn (2523)

Event Date 12/05/2020

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

Event Description

A health professional reported that during a surgical procedure there was no irrigation when the phacoemulsification (phaco) handpiece was inserted into the eye, the patient experienced a corneal wound burn.Additional information indicated the handpiece was exchanged and the irrigation worked fine.The wound did not seal with stromal hydration and two sutures were required to close the corneal wound.The patient has corneal haze at the incision site and will require follow up visits.Additional information was requested and received.

Manufacturer Narrative

Additional information has been provided in d.9., h.3., h.6.And h.10.The company service representative examined the system and was able to confirm but not replicate the reported irrigation event.The system was then tested and met all product specifications.With no additional, related information provided, the customer reported events of corneal burn, haze at the incision site, and sutures placed could not be confirmed.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The system was found to meet specifications; therefore, the root cause of the reported events cannot be determined conclusively.Corneal burn is an issue that is occasionally reported with cataract surgery.According to the pennsylvania patient safety advisory abstract: preventing corneal burns during phacoemulsification, (b)(6) 2010, vol.7, no.1: 23-25, most corneal burns can be traced to issues related to surgical technique and not to malfunctioning equipment.The manufacturer internal reference number is: (b)(4).

• 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: 11117711
• MDR Text Key: 225103673
• Report Number: 2028159-2021-00020
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OZIL TORSIONAL PHACO HANDPIECE; OZIL TORSIONAL PHACO HANDPIECE
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR