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

Model Number BL2351

Device Problem Unexpected Shutdown (4019)

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

Event Date 04/03/2023

Event Type  malfunction  

Manufacturer Narrative

The field service technician on site could not reproduce the reported problem.As precaution all connections were secured on top of power supply.Replaced electrical cord, as the cord was old.The device history was reviewed and found to meet manufacturing specification.This investigation is ongoing.

Event Description

The system shutdown twice during surgery.No patient impact reported or medical intervention required.They changed out the power strips as a precaution.

Manufacturer Narrative

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 VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 16831415
• MDR Text Key: 314169135
• Report Number: 0001920664-2023-70040
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757770524495
• UDI-Public: (01)00757770524495(11)221017(21)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL2351
• Device Catalogue Number: BL11145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2023
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1