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

Model Number BL2351

Device Problem Loss of Power (1475)

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

Event Date 02/12/2024

Event Type  malfunction  

Manufacturer Narrative

The product has been requested for return and has not been received.The device history record has been reviewed and this module met specifications on the date of manufacture.The investigation is underway.

Event Description

The user facility reported that the system shutdown during a surgical procedure.The power cord was inspected and found to be connected securely.The eye was stabilized and a second system was brought in to complete the procedure.There was no patient impact, injury and no need for additional surgical maneuvers/treatment required as a result.

Manufacturer Narrative

Evaluation results showed the system ceased effective operation resultant from the user actively proceeding with multiple surgeries after being warned about the inadequate state of the foot control battery and having failed to take appropriate mitigation.Logfiles document these conditions.This system had not received prior depot attention and was running at a gui level outdated as of (b)(6) 2022.There was an 11cm penetrating gash in the rear skin even with the iv pole weight assembly to the right of the laser warning label, while the pole''s upper bracket had been bent and damaged (both screw receivers rotating), with two of the cover plugs being absent.Forty-four surgeon settings flies were programmed on this unit.Product evaluation confirmed the failure mode.Reported system shutdown was due to improper maintenance and outdated gui configuration.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing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.The investigation is complete.

• Brand Name: POWER SUPPLY II
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 18870911
• MDR Text Key: 337306042
• Report Number: 0001920664-2024-70025
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757770524532
• UDI-Public: (01)00757770524532(11)200127
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2020
• 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
• Treatment: STELLARIS SYSTEM AND ACCESSORIES