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

Model Number TABLETOP

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Collapse (2416)

Event Date 01/26/2021

Event Type  malfunction  

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 the ophthalmic surgical system and cassette had intraocular (iop) compensation issue during a surgical procedure.The cassette was exchanged and the problem has not recurred.The case was completed with no impact to the patient.Additional information has been requested and received that no system message was displayed during the vitrectomy procedure.There was an issue with the anterior chamber collapse of the patient.There was no patient harm reported.

Manufacturer Narrative

The company representative was unable to replicate the reported event.Based on assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.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: 11338864
• MDR Text Key: 233732683
• Report Number: 2028159-2021-00156
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 04/26/2021
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION PROCEDURE PAK