MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM; ENDOILLUMINATOR

Catalog Number 8065750290

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

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.A sample has been received by manufacturing that has not yet been evaluated.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that an ophthalmic console exhibits advisory messages and was unable to use light ports one and two before vitrectomy surgery.The surgery was completed on the same day by using the ports three and four and no issues experienced.The patient impact was not reported.

Manufacturer Narrative

The company representative was able to replicate the reported event.The lamp was replaced to address the issue and was returned for testing on this investigation.The system was tested and found to meet product specifications.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.The lamp was received for testing on this investigation.A visual assessment of the returned sample revealed discoloration of the of the wire components.The returned sample was installed into a system and tested.No system message displayed and both ports passed output specification.The reported event was not replicated.The root cause of the reported event is attributed to component wear.The root cause of the reported event is attributed to component wear.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM
• Type of Device: ENDOILLUMINATOR
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18408661
• MDR Text Key: 331497327
• Report Number: 2028159-2023-01727
• Device Sequence Number: 1
• Product Code: MPA
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K951627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750290
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1