MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NGENUITY DIGITAL VISUALIZATION SYSTEM; MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC

Catalog Number 8065753090

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

Patient Problems Head Injury (1879); Syncope/Fainting (4411); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/06/2021

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 customer reported that during a demonstration of the equipment a staff member felt sick while watching the three dimensional image, took off the 3d glasses and then fainted.The staff member hit their head and part of the teeth were broken and there was a cut on the mouth.The staff member was taken to the hospital were a full examination of the head was performed.There were no abnormalities noted.The procedure was completed with no harm to the patient.

Manufacturer Narrative

Additional information has been provided in h.6.And h.10.Additional information was requested related to impacted staff¿s medical and ocular history.However, no information was provided.As a result, the clinical evaluation cannot be performed at this time.There is no evidence provided to signify device non-conformity.Based on the information obtained for this investigation, the root cause is unable to be determined conclusively.The manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.Root cause, 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

Additional information has been received indicating that services was not requested for the system.There was no issue during set up of the system.Current condition of the affected staff member was not reported.

• Brand Name: NGENUITY DIGITAL VISUALIZATION SYSTEM
• Type of Device: MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 11907433
• MDR Text Key: 253461343
• Report Number: 2028159-2021-00564
• Device Sequence Number: 1
• Product Code: EPT
• UDI-Device Identifier: 00380657530908
• UDI-Public: 380657530908
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065753090
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention