MAUDE Adverse Event Report: BAUSCH + LOMB 27 GA. BI-BLADE VITREOUS CUTTER COMBINED WIDE-FIELD STELLARIS ELITE PACK; UNIT, PHACOFRAGMENTATION

Model Number	SE5527WVB
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in mauritius reported during surgery, the bi-blade cutter was found to be inoperative while aspiration continued.Another pack was opened to complete the surgery.There was no impact to the patient.
Additional Manufacturer Narrative
The device history was reviewed and found to meet manufacturing specification.This investigation is ongoing.
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 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.

• Brand Name: 27 GA. BI-BLADE VITREOUS CUTTER COMBINED WIDE-FIELD STELLARIS ELITE PACK
• 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: 24268679
• Report Number: 0001920664-2026-00013
• Device Sequence Number: 9947979
• Product Code: HQC
• UDI-Device Identifier: 00757770060023
• UDI-Public: (01)00757770060023(17)270624(10)X6511
• Combination Product (Y/N): N
• Initial Reporter Country: MP
• PMA/510(K) Number: K170052
• 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,Followup
• Report Date (Section B): 03/26/2026

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: SE5527WVB
• Device Lot Number: X6511
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• 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