MAUDE Adverse Event Report: BAUSCH + LOMB, INC. 25G POSTERIOR X PACK WITH V&AFI&WF; UNIT, PHACOFRAGMENTATION

Model Number	BL5425WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing and sterilization records were reviewed and found to be acceptable.Although the product has not been received for evaluation, a review of the videos attached to the complaint file was performed.The original packaging is not visible in the photos.However, the videos confirm that the cutter is a 25ga.The part number and lot number cannot be verified or determined.The cutter can be seen in a surgical setting.First being placed in the patient's eye.The sound of the cutter can be heard indicating that the cutter is on, or activated, and should be cutting.However, the tissue is not being cut in the eye, though some debris and tissue are being pulled toward the tip of the cutter which shows that the cutter is aspirating.The second video shows the tip of the cutter being held by a gloved hand in a metal bowl containing a small amount of fluid.Again, the sound of the cutter can be heard, indicating that the cutter has been activated or is on.The fluid can be seen being pulled through the tubing, verifying that the cutter is aspirating.While the failure mode was confirmed, the root cause of this complaint could not be determined through video analysis only.The investigation will be reopened if the product is returned.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.
Event or Problem Description
A user facility in china reports that the vitrectomy cutter is not cutting while still aspirating during the operation.It was reported that there was no patient impact/injury.
Additional Manufacturer Narrative
The product was returned and evaluation completed.One opened (b)(6) pack from lot x5953 was returned.Visual inspection found the tubing wadded and tangled up inside the pack tray.The assembly is used.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.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 was stuck.The inner needle is bound up.It should be noted that a bent needle and an inner needle binding up could contribute to poor cutting performance.Due to evidence of use, the cause of the bent needle cannot be determined.This assembly was sent to the vendor for further evaluation.While the failure mode was confirmed, the root cause of this complaint could not be determined due to the returned condition of the sample.The lot history, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action is required.The investigation is complete.

• Brand Name: 25G POSTERIOR X PACK WITH V&AFI&WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC.; 4100 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 blvd; saint louis, MO 63122 ; 6362263089
• MDR Report Key: 21577296
• Report Number: 0001920664-2025-00025
• Device Sequence Number: 15561264
• Product Code: HQC
• UDI-Device Identifier: 00757770058648
• UDI-Public: (01)00757770058648(17)250902(10)X5953
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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: 09/02/2025
• Device Model Number: BL5425WV
• Device Lot Number: X5953
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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 SYSTEM AND ACCESSORIES
• Patient Sex: Unknown