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	01/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 25ga bi-blade vitrectomy cutter was returned in a plastic bag, along with an se5425wvb pack label from lot x4894.The tip protector and the rest of the pack components were not returned.The needle was bent.The port window was in the opened position with debris and solutions visible in and around the port and on the outer needle shaft.There was fluid in the tubing.This cutter looked used.The back cap was correctly aligned 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 elite system.The cutter did not cut, but did aspirate.It should be noted that a bent needle could contribute to poor cutting performance.Due to the dirty, damaged condition of the returned part the cause for the bent needle could not 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.
Event or Problem Description
The user facility reported the vitrectomy cutter was not working.There was no medical intervention required.
Additional Manufacturer Narrative
Correction: d4 correct udi number.

• 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, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 18758122
• Report Number: 0001920664-2024-70028
• Device Sequence Number: 6271322
• Product Code: HQC
• UDI-Device Identifier: 00757770059775
• UDI-Public: (01)00757770059775(17)250206(10)X4894
• 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,Followup
• Report Date (Section B): 02/05/2024

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: 02/06/2025
• Device Model Number: SE5425WVB
• Device Lot Number: X4894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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
• Patient Sex: Unknown