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

Model Number ASKU

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

Patient Problems Corneal Edema (1791); Eye Injury (1845); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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.Comparisons of the clinical outcomes of centurion active fluid system with a low iop setting and gravity fluid system with a normal iop setting for cataract patients with low corneal endothelial cell density.Yinan liu, jing hong, xiaoyong chen the manufacturer internal reference number is: (b)(4).

Event Description

A clinical study of comparing active fluidics group and gravity fluidics group revealed that post operatively there was a difference in the corneal endothelial cell loss rate between the active-fluidics group and gravity fluidics groups.Patients aged 60 to 85 years old with senile cataracts and a decrease in the corneal endothelial cell density (ecd) were selected and randomly divided into the afs group and the gfs group.Forty eyes of the afs group and 32 eyes of the gfs group were enrolled.Post surgery, the patient pain level graded by nrs showed significant differences between groups, indicating higher pain levels of the gfs group (p<0.0001).Change in cct at 1-day visit and loss rate of ecd at 1-month visit of the gfs group were found to be significantly higher than the afs group for both subgroups.These were observed within 1-month follow-up.Topical eye drops of 0.3% levofloxacin, 1.0% prednisolone acetate and 0.1% diclofenac sodium were used for 1 month post-operatively.The corneal endothelial cell loss rate in the active-fluidics group was significantly lower than that in the gravity-fluidics group.

Manufacturer Narrative

The company representative was unable to confirm nor replicate the reported event.The system was tested and found to meet product specifications.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.Based on the information obtained, the root cause of the reported event is inconclusive.Manufacture will continue to monitor data for evidence of adverse trending and take further action, as appropriate.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
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17918985
• MDR Text Key: 325455954
• Report Number: 2028159-2023-01384
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/26/2023

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 Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 11/29/2023
• Supplement Dates FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DICLOFENAC SODIUM.; LEVOFLOXACIN.; PREDNISOLONE ACETATE.
• Patient Outcome(s): Other