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 Corneal Edema (1791); Burn, Thermal (2530)

Event Date 12/23/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A surgeon reported that a patient experienced an incisional burn, in the right eye, during a cataract procedure.The patient presented with corneal edema, in the right eye, following surgery.The surgeon suspects the ultrasound was too strong.The edema persisted for 30 days.

Manufacturer Narrative

Correction e.1.Additional information provided in h.6.And h.10.No further information was provided.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported event could not be confirmed.The root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Event Description

A company representative offered the surgeon surgical accompaniment and support with supplies to rule out parameters, but the doctor refused, indicating he did not want to risk more patients corneas.

Manufacturer Narrative

Additional information provided in b.5.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: 10499331
• MDR Text Key: 205876407
• Report Number: 2028159-2020-00709
• 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,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/07/2020
• Supplement Dates Manufacturer Received: 09/18/2020; 09/25/2020
• Supplement Dates FDA Received: 09/25/2020; 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other