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

Catalog Number 8065751763

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2020

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.(b)(4).

Event Description

A surgeon reported that after noting laser assisted cataract procedure in the right eye, a posterior capsular tear was observed during phacoemulsification.The surgeon achieved a well centered flat dock free of bubbles.All control points placed properly and the laser portion of the case completed with no issues and excellent patient cooperation.The surgeon had one small area of capsulotomy that felt sticky but managed with no issues.The surgeon feels the tear could have occurred during hydrodissection or phaco but unsure at this time.An anterior vitrectomy was performed and implantation of an intraocular lens was inserted without any further issue.It was noted that this was the surgeon's first day of laser capsulotomy system.

Manufacturer Narrative

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 events could not be confirmed.The root cause of the reported events 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: 10642516
• MDR Text Key: 210362350
• Report Number: 2028159-2020-00807
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

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: 09/22/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LENSX LASER; MA60AC IOL
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR