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

Model Number TABLETOP

Device Problem Component Missing (2306)

Patient Problem Retinal Injury (2048)

Event Date 07/15/2021

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 customer reported that an ophthalmic operating console's laser filter was missing during a surgery.The surgeon had left macular laser injury.The retina specialist examined the eye and optical coherence tomography (oct) and angiogram were performed which showed retinal pigment epithelium (rpe) damage.The acute symptoms have been resolved but there is a possibility of long-term choroidal neovascularization (cnv).

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.The root cause of the reported event can be attributed to user handling.Data will continue to be monitored for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION 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: 12342808
• MDR Text Key: 267280921
• Report Number: 2028159-2021-00920
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657511501
• UDI-Public: 00380657511501
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PUREPOINT LASER; PUREPOINT LASER
• Patient Outcome(s): Other