MAUDE Adverse Event Report: BAUSCH + LOMB 25G BI-B COMBINED 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	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.This investigation is ongoing.
Event or Problem Description
The user facility reported the cutter stopped cutting, but continued to aspirate.
Additional Manufacturer Narrative
The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.This investigation is ongoing.
Additional Manufacturer Narrative
The evaluation has been completed.One opened se5425wvb pack from lot x4144 was returned.The expiration date on the label is 2024-oct-03.The tip protector was not returned.The needle was bent.The port window was in the opened position.There was dried solution visible all over the cutter, needle.The cutter looked used, as there was fluid in the lines.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 elite system.The cutter did not cut.The inner needle was binding up, preventing cutting and aspiration.It should be noted that a bent needle could contribute to poor cutting performance due to friction and binding between the inner and out needle assemblies.Due to the returned condition, and evidence of use, the root cause of the bent needle cannot be determined.This investigation is complete.
Additional Manufacturer Narrative
Correction: d4 udi number.

• Brand Name: 25G BI-B COMBINED 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: 17877162
• Report Number: 0001920664-2023-70103
• Device Sequence Number: 17239957
• Product Code: HQC
• UDI-Device Identifier: 00757770059775
• UDI-Public: (01)00757770059775(17)241003(10)X4144
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup,Followup
• Report Date (Section B): 09/14/2023

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: 10/03/2024
• Device Model Number: SE5425WVB
• Device Lot Number: X4144
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; 10/04/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 11/06/2023; 12/13/2023; 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT
• Patient Sex: Unknown