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

Model Number BL2351

Device Problem Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device history record review was completed with no anomalies noted, and the power supply meeting functional test specifications.The product was not returned, rather a field service technician was sent to the site.The technician checked the system and found the power cable that connects to the back of the system loose.The connection was tightened as was the fixing screw.All other power supply cable connections were checked found to be okay.The system was challenged several times and found to be in good working order, functioning properly.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 was deemed necessary.The loose power cable caused intermittent power input, resulting in system shutdown.The most probable root cause was determined to be lack of maintenance.There was no patient impact or injury.The investigation is complete.

Event Description

A user facility in (b)(6) reported that the stellaris shut down twice during surgery.

• Brand Name: STELLARIS VISION ENHANCEMENT SYSTEM POWER SUPPLY II
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB INC; 1400 n goodman st; rochester NY 14609
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st louis, MO 63122
• MDR Report Key: 11314849
• MDR Text Key: 231407052
• Report Number: 0001920664-2021-00014
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2021

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: BL2351
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: STELLARIS VISION ENHANCEMENT SYSTEM