MAUDE Adverse Event Report: BAUSCH + LOMB 23G POSTERIOR PROCEDURAL PACK WITH V&WF; UNIT PHACOEMULSIFICATION

Model Number	BL5223WV
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 china reported aspiration continued when the vitrectomy cutter stopped cutting during the operation.There was no effect on the patient.
Additional Manufacturer Narrative
Although the product was not received for evaluation, we reviewed a video provided by the customer.The original packaging was not visible in the video.The part number and lot number cannot be verified or determined.However, the video clearly showed a 23ga vitrectomy cutter in a surgical setting.The tip of the vitrectomy cutter was in a priming cup.The tubing was fully assembled and correctly attached to the stellaris system.The cutter was activated with the cut rate set to 5000 c.P.M.The cutter can be heard humming indicating that the cutter was on, but the fluid in the cup was not turbulent which could indicate that the inner needle was not moving.In addition, the system vacuum rate was set to 200 mmhg.The vitrectomy cutter aspiration tubing had some fluid and fluid droplets visible in the line and, but flow can be seen moving through the aspiration line and no fluid can be seen dripping into the collection cassette.The cutter does not appear to be aspirating or cutting.It should be noted that tight tubing connections cannot be verified by viewing the video alone.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.This investigation is ongoing.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.
Additional Manufacturer Narrative
One opened bl5223wv pack from lot x6352 was returned.The expiration date on the label is 2025-nov-25.Visual inspection found the tubing loosely coiled inside the pack tray.The 23ga.Vitrectomy cutter was lying on top of the rest of the components.The vitrectomy cutter tip protector was not returned.The needle was bent.The port window was in the open position.The cutter tubing was dirty with fluid in the aspiration line.The back cap was aligned correctly 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.There were bubbles in the aspiration line.Further inspection found the aspiration line was loose on the barb on the back cap and comes off easily.The cutter has intermittent cutting due to the air leak.It should be noted that an air leak and bent needle can contribute to poor cutting performance.Due to the evidence of use, and the returned condition with a bent needle and loose tubing, it cannot be determined when the needle became bent, or when the tubing became loose.

• Brand Name: 23G POSTERIOR PROCEDURAL PACK WITH V&WF
• Common Device Name: UNIT PHACOEMULSIFICATION
• 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 ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 23097328
• Report Number: 0001920664-2025-00105
• Device Sequence Number: 9383459
• Product Code: HQC
• UDI-Device Identifier: 00757770058587
• UDI-Public: (01)00757770058587(17)251125(10)X6352
• 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
• Report Date (Section B): 07/24/2025

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: 11/25/2025
• Device Model Number: BL5223WV
• Device Lot Number: X6352
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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
• Patient Sex: Unknown