MAUDE Adverse Event Report: BAUSCH + LOMB 25GA COMBINED VITRECTOMY PACK WITH VALVES AND AFI&WF; UNIT PHACOEMULSIFICATION

Model Number	BL5525WVX
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned and evaluated.One collection cassette assembly and one 25ga.Vit cutter assembly were returned with a cut out portion of a tyvek labeled bl5525wvx from lot x5607.The expiration date on the label is 2025-jun-23.The assemblies were received wadded and tangled up inside a red plastic bag.Inspection of the cutter found there was dried solution visible in the tubing.The needle was bent.The port window was in the opened position and there was damage on the edges.There was debris visible all over the outer needle shaft inside the port window.The cutter looked used.The back cap was aligned correctly with the vent holes on 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 and the cutter did not cut.The inner needle was binding up and did not reach the cutting edge.The product evaluation confirmed the failure mode.Due to the evidence of use, the returned condition, wadded and tangled up, the cause of the bent needle could not be determined.The device history was reviewed and found to meet manufacturing specifications.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
It was reported that during procedure, the cutter stopped working and aspiration continued normally.The cassette was changed immediately, and the procedure was successfully completed.There was no patient impact/injury due to this event.

• Brand Name: 25GA COMBINED VITRECTOMY PACK WITH VALVES AND AFI&WF
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 3365 tree ct. industrial blvd.; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 22589198
• Report Number: 0001920664-2025-00092
• Device Sequence Number: 9180053
• Product Code: HQC
• UDI-Device Identifier: 00757770059126
• UDI-Public: (01)00757770059126(17)250623(10)X5607
• Combination Product (Y/N): N
• PMA/510(K) Number: K954340
• 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
• Report Date (Section B): 06/19/2025

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: 06/23/2025
• Device Model Number: BL5525WVX
• Device Lot Number: X5607
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT.
• Patient Sex: Unknown