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

Model Number TABLETOP

Device Problems Decrease in Suction (1146); Incorrect, Inadequate or Imprecise Result or Readings (1535); Pressure Problem (3012)

Patient Problem Corneal Ulcer (1796)

Event Date 07/17/2020

Event Type  Injury  

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 nurse reported to company representative that the intraocular pressure (iop) control of the system was not working.Additional information was requested and received.During priming for a combined phacoemulsification (phaco) retinal procedure the test passed but there was a strange noise.While preforming the phaco portion of the procedure the intraocular pressure (iop) was displayed as 80mmhg.The surgeon palpitated the eye and it felt very hard.He lowered the pressure to 30mmhg but it seemed that the display was incorrect.There were no system messages displayed.The handpiece and consumables were exchanged, but there was the issue of the system could not be reprimed.All the materials were exchanged again and the test passed although it took ten minutes to do so.The surgery progressed to the vitrectomy phase and the vitrectomy probe aspiration was very weak.The surgeon was able to complete the case with an alternate system.Due to the extended time to perform the surgery the patient experienced a corneal ulcer located in the visual axis.The corneal ulcer has recovered.

Manufacturer Narrative

Additional information has been provided in d.10., h.3., h.6.And h.10.The company service representative examined the system and was able to confirm but not replicate the reported priming event.The company service representative was not able to confirm or replicate the reported iop issue or aspiration issue.As a preventative measure (pm), the fluidics module was replaced.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.No problem was found with the system, the root cause of the reported events 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: 10379840
• MDR Text Key: 202103934
• Report Number: 2028159-2020-00607
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 07/20/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 10/12/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK; CONSTELLATION SURGICAL PROCEDURE PAK
• Patient Outcome(s): Other