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

Model Number TABLETOP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chemosis (1775); Edema (1820); Intraocular Pressure, Delayed, Uncontrolled (1936)

Event Date 11/18/2020

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

Event Description

A health professional reported that during a retinal detachment surgery, intraocular pressure (iop) during vitreous intervention was not stable and the eye ¿clapped¿.Iop had to be raised to high values.After the surgery, the patient had a pronounced edema of the eyelids, moderate chemosis of the conjunctiva, and mild edema of the corneal epithelium.The patient was prescribed a combined antibiotic treatment (tobramycin).The condition was gradually returning to normal.The signs of puffiness disappear after about a week.Additional information received clarified that increased iop and need to increase the iop control during surgery.

Manufacturer Narrative

The system was examined.The company representative did not indicate, finding any issues that would be associated with the reported event.The fluidic module was replaced.The system was tested and found to meet product specifications.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.Based on the information obtained, 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: 10976355
• MDR Text Key: 220983286
• Report Number: 2028159-2020-01083
• 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: 04/28/2021

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: 11/23/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR