MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS MICRO INCISION VACUUM PACK; UNIT PHACOEMULSIFICATION

Model Number	BL5113
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in france reported that during surgery for a very advanced and dense cataract requiring a lot of ultrasounds, small pieces of the needle's coating were released into the eye.Another needle was requested, and the same thing happened.These fragments are still present in the patient's eye, without causing any impact to the patient.
Additional Manufacturer Narrative
Although requested, the lot number was not provided, therefore the udi-pi is not available.The root cause of this complaint could not be determined as the complaint unit was not available for analysis.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.Report 1 of 2 see related medwatch report number 0001920664-2026-00004.

• Brand Name: STELLARIS MICRO INCISION VACUUM PACK
• Common Device Name: UNIT PHACOEMULSIFICATION
• 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 ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 24232695
• Report Number: 0001920664-2026-00003
• Device Sequence Number: 21379479
• Product Code: HQC
• UDI-Device Identifier: 00757770057238
• UDI-Public: (01)00757770057238
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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
• Operator of Device: Health Professional
• Device Model Number: BL5113
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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