MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ELITE ADAPTIVE FLUIDICS BASIC PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL5114
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Eye Injury (1845); Capsular Bag Tear (2639)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer.The investigation of this event is ongoing.
Event or Problem Description
The user facility in the united kingdom reported that during preparation for the procedure, there was continuous running of excess quantity of irrigation fluid.This also occurred during the procedure.The patient had iris trauma and a posterior capsular tear and was sent to another health center for cataract insertion.The eye is still under review but is starting to heal.
Additional Manufacturer Narrative
Visual inspection found the tubing wrapped around the collection cassette.The assembly is dirty with fluid in the lines and collection cassette.Further inspection found the iv spike and drip chamber along with a small section of the irrigation and aspiration tubing have been cut off and were not returned.In addition, there is an unknown section of tubing with an unknown connector inserted into the female connector of the clear aspiration tubing.A partial functional test was performed by using a syringe and a beaker of water to check for leaks.The complaint evaluation technician pushed water through the tubing and found no fluid leaking.The unknown section of tubing was also tested and found no leaks.This assembly cannot function properly in this condition.No further testing could be performed.There is insufficient detail to determine the root cause of this complaint.This type of complaint could be caused by a surgical equipment issue or could be related to the clinic's setup/parameters.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.The investigation is complete.

• Brand Name: STELLARIS ELITE ADAPTIVE FLUIDICS BASIC PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 6362263089
• MDR Report Key: 22800073
• Report Number: 0001920664-2025-00097
• Device Sequence Number: 20904627
• Product Code: HQC
• UDI-Device Identifier: 00757770057542
• UDI-Public: (01)00757770057542(17)280111(10)X7596
• Combination Product (Y/N): N
• 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
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: BL5114
• Device Lot Number: X7596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown