MAUDE Adverse Event Report: BAUSCH + LOMB 25GA 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	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 can not cut while still aspirating.No impact to the patient was reported.
Additional Manufacturer Narrative
One opened bl5425wv pack from lot x5029 was returned.The expiration date on the label is 2025-feb-27.The cutter was lying loose on the top of the pack components.The tip protector was not returned.The needle was not bent.The aspiration line had been removed from the vitrectomy cutter back cap, and the extension handle was loose on the tubing.The port window was in the opened position.There was debris visible in and around the port.There was what looks liked dried blood around the port opening and dried solutions visible on the outer needle shaft.There was fluid droplets in the aspiration line.This 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 does not cut properly.There are bubbles appearing in the aspiration line.Often many microbubbles with larger bubbles also.This cutter has an air leak and does not cut as it should.The product sample will be sent to the vendor for additional evaluation.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.
Additional Manufacturer Narrative
While the failure mode was confirmed, the root cause of the bent inner needle assembly could not be determined.The supplier performed functional testing on the cutter assembly.The supplier determined that the cutter assembly did not move and the air was leaking out of the vent holes near the cap.The inner needle assembly was severely bent.These components are 100% functional tested by the supplier prior to being shipped.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: 25GA 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; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 20300036
• Report Number: 0001920664-2024-00119
• Device Sequence Number: 20764918
• Product Code: HQC
• UDI-Device Identifier: 00757770058648
• UDI-Public: (01)00757770058648(17)250227(10)X5029
• 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
• Report Date (Section B): 09/04/2024

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: 02/27/2025
• Device Model Number: BL5425WV
• Device Lot Number: X5029
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 11/25/2024; 03/04/2025
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 12/16/2024; 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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