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

Model Number TABLETOP

Device Problem Collapse (1099)

Patient Problems Intraocular Pressure, Delayed, Uncontrolled (1936); Collapse (2416)

Event Date 01/10/2020

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.(b)(4).

Event Description

A physician reported intraocular pressure issues with the system.The patient experienced anterior chamber collapse.The case was completed.Additional information was requested and received which indicated no system messages were displayed and the case was completed.Patient impact is unknown.Additional information received indicated there was intermittent collapse and loss of pressure in the patient's right eye.There was no medical or surgical intervention provided.The was no harm to the patient and the procedure was completed.This is one of two reports from this facility.

Manufacturer Narrative

Additional information has been provided in g.1., g.2.Corrected information has been provided in h.10.  a supplemental medical device report (smdr) # 01 is being filed to correct the g.4 date on the prior filed supplemental report.Incorrect date of 01/13/2020 is being corrected to 01/15/2020.  the system was examined.The company representative did not indicate finding any issues that would be associated with the reported event.The manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The system was found to have no problems.Therefore, the root cause of the reported event 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: 9663228
• MDR Text Key: 181979033
• Report Number: 2028159-2020-00062
• 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: 03/06/2020

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?: No
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1