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

Model Number TABLETOP

Device Problem Gas/Air Leak (2946)

Patient Problems Retinal Injury (2048); Loss of Vision (2139)

Event Date 05/20/2020

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 physician reported that after a pars plana vitrectomy (ppv) surgery, a patient experienced vision loss and visual scotoma.The patient developed a blind spot in the infero temporal with damage to the retinal ganglion cell layer supero-nasal.The patient did not receive expansile gas.The patient underwent a fluid air exchange and the surgeon was suspecting the way the air was introduced into the eye could have caused or contributed to the scotoma.No system message was displayed.The patient issues were not resolved, still had blind spot.

Manufacturer Narrative

The customer did not request service for the system.No sample has been received.Based on qa assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.The manufacturer internal reference number is:(b)(4).

Manufacturer Narrative

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

Event Description

Further review of the reported event has clarified that the air flow from the infusion cannula during the air-gas exchange, angled directly towards the superior nasal paracentral retina may have contributed to the patient's visual scotoma.

• 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: 10922107
• MDR Text Key: 218906583
• Report Number: 2028159-2020-01028
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2021

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?: No
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 11/30/2020
• Supplement Dates Manufacturer Received: 03/26/2021; 05/05/2021
• Supplement Dates FDA Received: 04/14/2021; 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR