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

Model Number TABLETOP

Device Problems Unstable (1667); Suction Problem (2170)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2020

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 customer reported that during a combined cataract and vitrectomy procedure, in the right eye, the patient's intraocular pressure was unstable.In a follow up, it was reported that the surgeon was concerned with an intermittent lack of vacuum, only in heavy use, during the vitrectomy portion of the case.The surgeon reported using the compressor which was on a different operating room floor than the console that was being used for the case.

Manufacturer Narrative

The customer reported event of unstable intraocular pressure (iop) could not be confirmed.It should be noted that the customer stated that the consumables were sometimes reused.The customer also did not have their in-house compressor placed directly next to the system.However, if or how much these factors contributed to the reported events remains inconclusive.The root cause of the reported intermittent vacuum event can be attributed to the nonconforming fluidics module.The root cause of the reported unstable iop 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: 11341077
• MDR Text Key: 233739444
• Report Number: 2028159-2021-00162
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• 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
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR