MAUDE Adverse Event Report: BAUSCH + LOMB 25G POSTERIOR X PACK WITH V&AFI&WF; UNIT, PHACOFRAGMENTATION

Model Number	BL5425WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in china reported during an operation, the vitrectomy cutter was not sharp enough to cut well.While the cutter was stopped to be replaced, aspiration function continued at a significantly reduced rate, with many bubbles in the suction pipe.There was contact with the patient's eye, but no impact to the patient.
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.This investigation is ongoing.
Additional Manufacturer Narrative
The product evaluation has been completed.One opened bl5425wv pack from lot x6621 was returned.The expiration date on the label is 2026-jan-14.Visual inspection found the tubing is wadded and tangled up inside the pack tray.The assembly is clean and dry and does not appear to have been used.Inspection of the 25ga.Vit cutter found the tip protector is in place, as it should be.However, the needle is bent.The port window is in the open position.There is no visible solution in the tubing.The back cap is aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected, and no defects were found.A functional test was performed using a stellaris pc system.The back cap popped off and separated from the vit cutter body.This assembly cannot function properly in this condition.This investigation is ongoing.
Additional Manufacturer Narrative
The root cause is a component issue; when a functional test was performed using a stellaris pc system, the back cap popped off and separated from the vit cutter body.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.The investigation is complete.

• Brand Name: 25G POSTERIOR X PACK WITH V&AFI&WF
• 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: 22360864
• Report Number: 0001920664-2025-00085
• Device Sequence Number: 20974411
• Product Code: HQC
• UDI-Device Identifier: 00757770058648
• UDI-Public: (01)00757770058648(17)260114(10)X6621
• Combination Product (Y/N): N
• PMA/510(K) Number: K101325
• 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,Followup
• Report Date (Section B): 05/27/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2026
• Device Model Number: BL5425WV
• Device Lot Number: X6621
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 07/25/2025; 08/27/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/21/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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