MAUDE Adverse Event Report: BAUSCH + LOMB 25GA STELLARIS PC CUTTER; INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-PO

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	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested, not yet received.The device history was reviewed and found to meet manufacturing specifications.The investigation is ongoing.
Event or Problem Description
The user facility reported that during a vitrector anterior capsulotomy, the vitrectomy cutter was not cutting, and it seemed to not be working correctly.The aspiration continued to work.The physician was not able to capture anything, including apparently normal lens capsule.The capsule had a dense central plaque which the surgeon wasn't able to capture or cut.After cutting the bag with mst scissors, the surgeon still was not able to capture any of the apparently normal peripheral capsule either.The surgeon then switched to a 23g vit cutter and removed the nucleus without any issues.There was no patient injury.
Additional Manufacturer Narrative
The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.The investigation is ongoing.
Additional Manufacturer Narrative
One 25ga.Vit cutter was returned inside a biohazard bag.The original packaging was not returned.The tip protector was not returned.The needle was bent.The port window was in the opened position.There was fluid in the tubing.The back cap was correctly positioned with the vent hole in the side of the cutter body.The connectors were inspected, and no damage was found.A functional test was performed using a stellaris pc system.The cutter did not cut.The inner needle was bound up and did not move.It should be noted that a bent needle could contribute to poor cutter performance due to friction between the inner and out needle assemblies.There are two most probable root causes that may have contributed to this complaint.This is a known procedure complication since the physician stated that the capsule had a dense central plaque which they couldn't capture/cut.However, the less dense capsule was also not able to be captured.This is also a component issue due to the product evaluation that found the inner needle was bound up and unable to move.This investigation is completed.

• Brand Name: 25GA STELLARIS PC CUTTER
• Common Device Name: INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-PO
• 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 ; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 22358588
• Report Number: 0001920664-2025-00084
• Device Sequence Number: 8706156
• Product Code: HQE
• UDI-Device Identifier: 20841305109982
• UDI-Public: (01)20841305109982(17)270804
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K102222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2025

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
• Device Model Number: BL5625S
• Device Lot Number: X6721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/25/2025; 10/28/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/21/2025; 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT.
• Patient Sex: Unknown