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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2022

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 nurse reported that before vitrectomy both ports of the ophthalmic console would not emit light at the same time.The procedure was completed with out any reports of patient harm.

Manufacturer Narrative

Additional information provided in sections d.9.H.3.H.6.And h.10.The service history was reviewed for the system.No service record relevant to the complaint reported event was found.However, the lamp was returned on this investigation for evaluation.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 non-conformance-based review of the batch/lot/serial number was performed and a potential contributing factor to the reported complaint was identified.The internal investigation was opened but was later determined to be irrelevant to this reported event.The lamp was received for this investigation.A visual assessment of the returned sample revealed no obvious nonconformity.Sample testing of the returned part was performed.The lamp was installed into a system, and no system message displayed and there was no problem found.The reported event was not replicated.The system was found to have no problem.Therefore, the root cause of the reported event is inconclusive.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: 15641550
• MDR Text Key: 306155847
• Report Number: 2028159-2022-01481
• Device Sequence Number: 1
• Product Code: MPA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K951627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• 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