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 Injury (2348)

Event Date 01/14/2019

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

Event Description

A surgeon reported that during phacoemulsification of a cataract procedure there was an increase in vacuum.The patient experienced an anterior capsular bag tear.A virectomy was performed and an alternate intraocular lens was implanted.The procedure was completed.The patient was referred to a retina specialist.Additional information has been requested but not received.This is two of two reports from this facility.

Manufacturer Narrative

The company service representative examined the system and no problem was found.The system was then tested and met all product specifications.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 posterior capsule.The system was found to meet specifications; therefore, the root cause of the reported event 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: 8374795
• MDR Text Key: 137296471
• Report Number: 2028159-2019-00291
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• 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
• Date Manufacturer Received: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUSTOM PAK; DUOVISC VISCOELASTIC SURGICAL DEVICE; CUSTOM PAK; DUOVISC VISCOELASTIC SURGICAL DEVICE
• Patient Outcome(s): Required Intervention