MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS PREMIUM PHACO PACK-1.8MM ANG; UNIT, PHACOFRAGMENTATION

Model Number	BL5114A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint sample was not available for evaluation, however the reported complaint notes that the cataract was particularly dense and that the surgeon was instructed on technique in that type of situation.The most probable root cause was determined to be user error due to the surgeon¿s technique.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.
Event or Problem Description
The user facility in united kingdom reported that on a case with a particularly dense cataract, tip blockage possibly occurred causing aspiration to pause momentarily.A small corneal burn resulted, requiring a suture and delaying the surgery up to 15 minutes.A bausch and lomb representative was present during the operation and instructed surgeon on how to prevent any burn if tip blocks, and adjusted phaco settings.

• Brand Name: STELLARIS PREMIUM PHACO PACK-1.8MM ANG
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 6362263089
• MDR Report Key: 22069915
• Report Number: 0001920664-2025-00070
• Device Sequence Number: 8711707
• Product Code: HQC
• UDI-Device Identifier: 00757770057702
• UDI-Public: (01)00757770057702(17)271025(10)X7198
• Combination Product (Y/N): N
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

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: BL5114A
• Device Lot Number: X7198
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT
• Patient Sex: Unknown