MAUDE Adverse Event Report: BAUSCH + LOMB 25 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI&WF; UNIT PHACOEMULSIFICATION

Model Number	BL5425WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The user facility in china reported that the vitrectomy cutter was not cutting yet was still aspirating during surgery.There was no patient impact.
Additional Manufacturer Narrative
Visual inspection found the tubing wadded and tangled up inside the pack tray with the rest of the pack components.The reflex blub is missing and was not returned.The vit cutter tip protector was not returned.The needle is bent.The port window is in the opened position.The back cap is aligned correctly with the vent hole in the side of the cutter body.This cutter looks used.The connectors were inspected, and no damage was found.A functional test was performed using a stellaris pc system.The cutter had good aspiration.However, the cutter did not cut.The inner needle is not reaching the cutting edge.It should be noted that a bent needle could contribute to poor cutting performance due to friction between the inner and outer needle causing the inner needle to bind up.The root 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.The investigation is complete.

• Brand Name: 25 GA POSTERIOR 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, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 21107350
• Report Number: 0001920664-2025-00003
• Device Sequence Number: 8153343
• Product Code: HQC
• UDI-Device Identifier: 00757770058648
• UDI-Public: (01)00757770058648(17)250807(10)X5515
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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: 06/05/2025
• Device Model Number: BL5425WV
• Device Lot Number: X5515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown