MAUDE Adverse Event Report: BAUSCH + LOMB 23GA COMBINED PROCEDURAL PACK WITH INTEGRATED VENTED AFI&WF; UNIT, PHACOFRAGMENTATION

Model Number	BL5323WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested but not yet received.Manufacturing and sterilization records were reviewed and found to be acceptable.This investigation is ongoing.
Event or Problem Description
The user facility in china reported the vitrectomy cutter did not cut during the surgery; however, aspiration continued.There was no medical intervention required.
Additional Manufacturer Narrative
One opened bl5323wv pack from lot x4775 was returned.The expiration date on the label was 2025-jan-16.The assembly was dirty with fluid in the lines.The extension handle was attached to the vitrectomy cutter.The tip protector was not returned.The needle was bent.The port window was in the opened position.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 pc system.The cutter did not cut or aspirate.The inner needle binds up, blocking the port opening and does not move.The cutter cannot function properly in this condition.Due to the returned condition having no tip protector on the vitrectomy cutter, and with evidence of use the cause of the bent needle cannot be determined.Unable to determine root cause(s) of the bent needle which prevented the device from functioning properly.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.Report 3 of 3, see related medwatch report numbers: 0001920664-2024-00067, 0001920664-2024-00069.

• Brand Name: 23GA COMBINED PROCEDURAL PACK WITH INTEGRATED VENTED AFI&WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INC.; 3365 tree court industrial bl; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 19270973
• Report Number: 0001920664-2024-00068
• Device Sequence Number: 6996930
• Product Code: HQC
• UDI-Device Identifier: 00757770058563
• UDI-Public: (01)00757770058563(17)250116(10)X4775
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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: 01/16/2025
• Device Model Number: BL5323WV
• Device Lot Number: X4775
• 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: 08/01/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT.
• Patient Sex: Unknown