MAUDE Adverse Event Report: BAUSCH + LOMB 25 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED 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	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.Manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is underway.
Event or Problem Description
A user facility in china reported that during an operation the vitrectomy cutter did not cut well, and continued to aspirate.The cutter was replaced.There was patient contact, and no impact to the patient.
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.The investigation is complete.
Additional Manufacturer Narrative
The product was returned and the evaluation completed.One opened pack was returned.Visual inspection found the cassette and tubing still coiled and taped together with the 25ga.Vit cutter wadded and tangled inside the pack tray.The tip protector is lying loose in on top of the components.Inspection of the cutter found the needle is bent.The port window is in the opened position.There is solution visible 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 inner needle is binding up and does not reach the cutting edge.Therefore, the cutter cannot cut.However, the cutter does aspirate.It should be noted that a bent needle could contribute to poor cutting performance.Due to the returned used condition, loose in the pack tray with no tip protector, the cause of the bent needle cannot be determined.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: 25 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI&WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 4100 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; saint louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd; saint louis, MO 63122 ; 6362263089
• MDR Report Key: 22395744
• Report Number: 0001920664-2025-00087
• Device Sequence Number: 14677904
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2025

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; 08/19/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/18/2025; 09/12/2025
• 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 SYSTEM AND ACCESSORIES.
• Patient Sex: Unknown