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

Catalog Number 8065753048

Device Problem Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/22/2019

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 that microreflux was too low and reported bubbles in the pipes during multiple procedures.The settings were modified by the company representative however, the surgeon then indicated that the parameters were too strong.There were no consequences for patients.Additional information has been requested.This is 2 of 4 reports being filed for this facility.

Manufacturer Narrative

The system was examined and the reported event was not replicated.The system was tested and found to meet product specifications.The manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.There was no consumable sample returned for evaluation.Therefore, the condition of the product could not be verified.There was no lot number identified with this complaint.Therefore, lot history and complaint history reviews could not be conducted.After final assembly, each cassette is verified that all required tests have been performed and all acceptance criteria were met.With no additional, related information provided, the customers reported event was not able to be confirmed.The root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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

Event Description

Additional information has been requested and clarification was received indicating that there were bubbles in the tubes and reflux was too weak during multiple ocular procedures in (b)(6) 2019.The bubbles occurred during all stages in the patient's eye.The number of events are unknown.The procedures were completed with difficulty.There were no system messages and no system alarm.

• 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: 9516953
• MDR Text Key: 177805919
• Report Number: 2028159-2019-02324
• 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,Followup
• Report Date: 04/22/2020

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 Catalogue Number: 8065753048
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 12/24/2019
• Supplement Dates Manufacturer Received: 12/24/2019; 04/15/2020
• Supplement Dates FDA Received: 01/21/2020; 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK; DUOVISC VISCOELASTIC SYSTEM (IBC), 000571, BEL