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

Model Number	SE5423WV
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing and sterilization records were reviewed and found to be acceptable.The device has been requested for evaluation.This investigation is ongoing.See related report- 0001920664-2023-70027.
Event or Problem Description
It was reported by the user facility that the cutter''s aspiration was not working.Aspiration stopped and complete removal of the lens was not possible, therefore a secondary surgery was required.The second surgery went fine, with no issues removing the remaining lens fragment.Surgery was a success.
Additional Manufacturer Narrative
Visual examination of the returned sample showed the needle is bent.The port window is in the opened position and there is dried solution visible all over the cutter, needle, collection cassette and tubing.The cutter looks used, as there is fluid in the lines.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.A functional test was performed using a stellaris elite system, and the cutter did not cut.The inner needle is binding up and blocking the port window, 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 dirtied, used, damaged condition in which the product was returned it was not possible to determine a root cause for the bent needle which as noted can contribute to poor cutting performance.We will continue to monitor for the reported complaint.No corrective action is required.See related report- 0001920664-2023-70027.

• Brand Name: 25G BI-B POSTERIOR ELITE W WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 16664434
• Report Number: 0001920664-2023-70026
• Device Sequence Number: 12245654
• Product Code: HQC
• UDI-Device Identifier: 00757770059508
• UDI-Public: (01)00757770059508(17)240604
• Combination Product (Y/N): Y
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2024
• Device Model Number: SE5423WV
• Device Lot Number: X3236
• 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
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown