MAUDE Adverse Event Report: Bausch + Lomb 25 ga. Bi-Blade Vitreous Cutter Combined Wide-Field Stellaris Elite Pack; Unit, Phacofragmentation

Model Number	SE5525WVB
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2026
Type of Reportable Event	Malfunction

• Brand Name: 25 ga. Bi-Blade Vitreous Cutter Combined Wide-Field Stellaris Elite Pack
• Common Device Name: Unit, Phacofragmentation
• Manufacturer (Section D): Bausch + Lomb; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): Bausch + Lomb Inc.; 3365 tree ct. industrial blvd.; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree ct. industrial blvd.; st. louis, MO 63122 ; +1(636)226-3089
• MDR Report Key: 50260681
• Report Number: 0001920664-2026-00065
• Device Sequence Number: 21504937
• Product Code: HQC
• UDI-Device Identifier: 00757770059768
• UDI-Public: (01)00757770059768(17)281011(10)X8945
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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: SE5525WVB
• Device Lot Number: X8945
• 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: 07/20/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2025
• 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
• Patient Sex: Unknown