MAUDE Adverse Event Report: BAUSCH + LOMB, INC. 23G BI-B POSTERIOR ELITE W WF; UNIT, PHACOFRAGMENTATION

Model Number	SE5423WVB
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.The device history record showed manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is ongoing.
Event or Problem Description
A user facility in china was using the vitrectomy cutter which was rattling and not cutting but continued to aspirate.There was patient contact but no effect the patient.
Additional Manufacturer Narrative
Evaluation completed.Visual inspection found the tubing and components wadded and tangled up inside the pack tray.There is fluid in the drip chamber, tubing, and fluid droplets visible in the collection cassette.Further inspection found the 23ga bi blade vit cutter loose at the bottom of the tray without the tip protector in place.However, the tip protector is loose in the pack tray.The needle is bent.There are droplets of dried solution in the vit cutter tubing.Closer inspection of the vit cutter found the aspiration barbed connector on the back cap is cracked and broken off with a piece of the connector remaining in the tubing.Therefore, the vit cutter cannot aspirate or cut.This assembly cannot function properly in this condition.The most probable root cause is unknown.The aspiration barb is separated from the vit cutter's cap.A supplier investigation request was issued to the vendor and the 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.The investigation is complete.

• Brand Name: 23G BI-B POSTERIOR ELITE W WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC.; 1400 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 ; 636226-3089
• MDR Report Key: 22003998
• Report Number: 0001920664-2025-00060
• Device Sequence Number: 13036420
• Product Code: HQC
• UDI-Device Identifier: 10757770059932
• UDI-Public: (01)10757770059932(17)270804
• Combination Product (Y/N): N
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

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
• Operator of Device: Health Professional
• Device Model Number: SE5423WVB
• Device Lot Number: X6707
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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