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

Catalog Number 8065751763

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Edema (1820)

Event Date 10/28/2019

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 that a patient presented with corneal decompensation, in the right eye, one day postoperative of cataract surgery.The patient was treated with corticosteroids and antiglaucoma medication.The edema is noted to persist despite treatment.The surgeon suspects the cause to be related to the ultrasound being too strong.It was reported that the surgeon reuses supplies such as cassettes and tips.

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

Corrected information provided in e.1.Additional information provided in b.5 the manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in h.6.And h.10.The customer did not request service for the system.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 cannot be determined conclusively.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: 10374849
• MDR Text Key: 201932780
• Report Number: 2028159-2020-00603
• 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,Followup
• Report Date: 12/03/2020

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: 8065751763
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 09/25/2020; 11/18/2020
• Supplement Dates FDA Received: 10/13/2020; 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR