MAUDE Adverse Event Report: BAUSCH + LOMB, INC. STELLARIS PC LASER MODULE; UNIT, PHACOFRAGMENTATION

Model Number	BL2271
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility in australia reports low laser output.The surgery could not be completed and the delay is unknown at this time.Power needed to be turned up to 700mw and duration 200ms and they were still struggling.
Additional Manufacturer Narrative
The device was not returned rather a technician was dispatched to perform an evaluation in site.The technician replaced the fiber optic cable and coupling.The device history record was reviewed.This module met specifications on the date of manufacture.The investigation is underway.See related 0001932402-2024-00003.
Additional Manufacturer Narrative
The product evaluation confirmed the failure mode malfunctioned fiberoptic cable and coupling.The most probable root cause is component issue.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.See related see related 0001932402-2024-00003.

• Brand Name: STELLARIS PC LASER MODULE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC.; 4100 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 blvd; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 19382349
• Report Number: 0001920664-2024-00076
• Device Sequence Number: 3770502
• Product Code: HQC
• UDI-Device Identifier: 00757770524532
• UDI-Public: (01)00757770524532(11)190129
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BL2271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown