MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS PC VISION ENHANCEMENT SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number BL2364

Device Problem Computer Operating System Problem (2898)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

A field service technician was on site found the computer would not boot up.This investigation is ongoing.On (b)(6) 2021, bausch + lomb received an email from cdrh/food and drug administration notifying the company that the report initially submitted on 04/12/2021 failed in the emdr system with an error due to the presence of the ¿}¿ character as part of the c-code value.There was no ack3 error message which notifies the company that the submission was rejected due to the character.The special character (¿}¿) has been removed and this report is being resubmitted.

Event Description

The user facility reported the stellaris system shut down.They couldn't find out if it powered down or just quit working.No patient impact was reported.

Manufacturer Narrative

Field service was on site; however, was not granted access to the stellaris unit.The customer has not responded to quotes for the evaluation/repair process.The device history was reviewed and found to meet manufacturing specification.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 11680815
• MDR Text Key: 249123112
• Report Number: 0001920664-2021-00038
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K101325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL2364
• Device Lot Number: 222
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1