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	05/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause of this complaint could not be determined as the complaint unit was not available for analysis at the time of this evaluation.The sterilization and lot history records were reviewed and found to be acceptable.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 italy reported that the vitrectome did not cut and the aspiration continued.The vacuum was changed from 550-640, which did not change anything.Another vitrectome was used to complete the procedure.

• 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 ; 6362263089
• MDR Report Key: 25562425
• Report Number: 0001920664-2026-00049
• Device Sequence Number: 18644999
• Product Code: HQC
• UDI-Device Identifier: 00757770059768
• UDI-Public: (01)00757770059768(17)281011(10)X8945
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/19/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS SYSTEM AND ACCESSORIES.
• Patient Sex: Unknown