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

Model Number	BL5423WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility from china reported that during surgery the vitrectomy cutter was not sharp enough to cut and aspiration continued.There was no impact to the patient.
Additional Manufacturer Narrative
The device has not been returned despite requests.Manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is underway.
Additional Manufacturer Narrative
Evaluation completed.One opened pack was returned.Visual inspection found the cassette and tubing still coiled and taped together with the 23 ga.Vit cutter wadded and tangled inside the pack tray.Inspection of the cutter found the tip protector was not returned.The needle is bent.The port window is in the opened position.There is solution visible in the tubing.The back cap is aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected, and no defects were found.A functional test was performed using a stellaris pc system.The inner needle is binding up and does not reach the cutting edge.The cutter cannot cut in this condition.It should be noted that a bent needle could contribute to poor cutting performance due to friction between the inner and outer needles.Due to the evidence of use and the returned condition with a bent needle it cannot be determined when the needle came to be bent.The most probable cause is a component issue.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.The investigation is complete.

• Brand Name: 23 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI&WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC.; 1400 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; saint louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blv; saint louis, MO 63122 ; 636226-3089
• MDR Report Key: 22481340
• Report Number: 0001920664-2025-00083
• Device Sequence Number: 20879006
• Product Code: HQC
• UDI-Device Identifier: 00757770058556
• UDI-Public: (01)00757770058556(17)260329(10)X7032
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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: 03/29/2026
• Device Model Number: BL5423WV
• Device Lot Number: X7032
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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 SYSTEMS AND ACCESSORIES
• Patient Sex: Unknown