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

Catalog Number 8065751763

Device Problem Increase in Suction (1604)

Patient Problem No Code Available (3191)

Event Date 01/13/2020

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 surgeon reported that aspiration was too strong at the start of phacoemulsification during a cataract procedure.The patient experienced an anterior capsular tear.Additional medical or surgical intervention was not required.The toric intraocular lens was implanted in the capsular as planned.It was noted that an occlusion occurred during the procedure.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information has been provided in h.3, h.6, and h.10.The company sales representative reviewed the surgeon¿s settings and the settings were fine.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.There is no evidence contained within the reported information at this time that indicates that the design or performance of the system had any effect on the integrity of the capsule.The root cause of the reported event of 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: 9776923
• MDR Text Key: 181796731
• Report Number: 2028159-2020-00177
• 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: 04/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 03/05/2020; 03/27/2020
• Supplement Dates FDA Received: 03/30/2020; 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED HANDPIECE.
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 65