MAUDE Adverse Event Report: Bausch + Lomb, Inc. 25GA Stellaris PC Cutter; Unit, Phacofragmentation

Model Number	BL5625S
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility in japan reported that when the cutter was used, the sound was different from normal.Aspiration was present, but the cut rate did not appear to increase.The cutter was replaced with another one and the procedure was completed after about a five minute delay.No patient impact or injury reported.
Additional Manufacturer Narrative
Despite multiple requests for the device, it has not been returned.Manufacturing and sterilization recordswere reviewed and found to be acceptable.The investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.

• Brand Name: 25GA Stellaris PC Cutter
• Common Device Name: Unit, Phacofragmentation
• Manufacturer (Section D): Bausch + Lomb, Inc.; 4100 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): Synergetics, Inc.; 3845 corporate centre dr.; o'fallon MO 63368
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd; saint louis, MO 63122 ; +1(636)226-3089
• MDR Report Key: 50210288
• Report Number: 0001920664-2026-00062
• Device Sequence Number: 6099008
• Product Code: HQC
• UDI-Device Identifier: 10757770059840
• UDI-Public: (01)10757770059840(17)281018(10)X8980
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: BL5625S
• Device Lot Number: X8980
• 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: 07/15/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Stellaris system and accessories.
• Patient Sex: Unknown