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

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 sterilization and lot history 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, but still aspirated during surgery.There was no effect on the patient.
Additional Manufacturer Narrative
One opened bl5323wv pack.The lot number and expiration date on the label have been torn off and were not returned.However, paperwork indicated that the lot number was x6366.The cutter was tangled up with the rest of the pack tubing.The tip protector was not received.The needle was bent.The port window was in the opened position with dried solutions visible around the part and on the outer needle shaft.The cutter looks used.The back cap was not fully 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 pc system.The cutter did not have clean cuts at the lower cut rates, as it pulled and left strings.Though the cutting improved as the cut rate was increased.It should be noted that a bent needle could contribute to poor cutting performance.Due to the returned condition, with the cutter tangled up in the pack tubing and with no tip protection, the cause of the bent needle cannot be determined.This investigation is ongoing.
Additional Manufacturer Narrative
The cutter was inspected and tested by manufacturing engineering department.The cause of bent needle cannot be determined.A bent needle can contribute to poor cutting performance.The aspiration barb vent hole seal aligned properly.The vendors response to a request for clarification about the aspiration barb vent hole and seal stated, the vent hole in the black rubber seal does not need to be aligned with the vent hole in the cap because there is an annular gap which allows free flow between them.What is shown is normal assembly which would not affect functionality (cutter not cutting).Investigation ongoing.
Additional Manufacturer Narrative
Due to the returned condition of the vitrectomy probe, the cause of the bent needle cannot 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.

• Brand Name: 23GA COMBINED PROCEDURAL PACK WITH INTEGRATED VENTED AFI&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: juli moore ; 6362263220
• MDR Report Key: 20639477
• Report Number: 0001920664-2024-00145
• Device Sequence Number: 7443291
• Product Code: HQC
• UDI-Device Identifier: 00757770058563
• UDI-Public: (01)00757770058563(17)251202(10)X6366
• Combination Product (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 10/18/2024

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: 12/02/2025
• Device Model Number: BL5323WV
• Device Lot Number: X6366
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 11/25/2024; 12/17/2024; 03/04/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/16/2024; 01/09/2025; 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT.
• Patient Sex: Unknown