MAUDE Adverse Event Report: BAUSCH + LOMB 25G BI-B POSTERIOR ELITE W WF; UNIT PHACOEMULSIFICATION

Model Number	SE5425WVB
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during surgery the vitrectomy cutter was not working.The cutter was still aspirating and creating bubbles in the line.There was no patient impact.
Additional Manufacturer Narrative
The product evaluation has been completed.One 25ga vit cutter was returned in a plastic biohazard bag without the original packaging.The paperwork returned with the product indicates that the part number is se5425wvb and the lot number is x6155.The tip protector was not received.The needle is not bent.The port window is in the opened position.There is fluid in the aspiration line.The back cap is aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected, and no damage was found.However, the connection that is approximately 9-10 inches from the back of the vit cutter is loose.After tightening the connectors on the aspiration tubing, a functional test was performed.This cutter had good clean cuts and aspirated as intended.No bubbles appeared in the lines during functional testing.It should be noted that a loose connection on the aspiration line could contribute to air leak which could produce bubbles in the line.Due to evidence of use, the cause of the loose connection on the aspiration line cannot be determined.Nor can it be determined if the aspiration line connectors were loose at the time of customer use.This complaint will be confirmed based on the loose connection in the aspiration line.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.

• Brand Name: 25G BI-B POSTERIOR ELITE W 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 ; 6362263089
• MDR Report Key: 21969581
• Report Number: 0001920664-2025-00061
• Device Sequence Number: 8142176
• Product Code: HQC
• UDI-Device Identifier: 00757770059775
• UDI-Public: (01)00757770059775(17)251007
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2025

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: 10/07/2025
• Device Model Number: SE5425WVB
• Device Lot Number: X6155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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
• Patient Sex: Unknown