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

Model Number BL2351

Device Problem Intermittent Loss of Power (4016)

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

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

A field service technician was dispatched to the site to evaluate the stellaris system on 06/24/21.The technician checked the power cord and switches, and tested the system.The system was reported to be in good working order, and passed all tests.The device history record review is complete with no anomalies noted.This module met specifications on it's manufacture date.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 required.The most probable root cause is unknown/inconclusive because the reported problem could not be duplicated.It was reported that there was patient contact, and no patient impact or injury.The investigation is complete.

Event Description

The user facility reported that the system shut down twice during surgery.

• Brand Name: POWER SUPPLY II
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122
• MDR Report Key: 12211824
• MDR Text Key: 262947430
• Report Number: 0001920664-2021-00088
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K101325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL2351
• Device Lot Number: 222
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1