MAUDE Adverse Event Report: BAUSCH + LOMB 23GA COMBINED VITRECTOMY PACK WITH VALVES AND 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	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in china reported that during procedure the vitrectomy cutter could not cut well.The aspiration rate was significantly reduced but continued with many bubbles in the suction pipe.They replaced the cutter and continued with a new one.There was no patient injury.
Additional Manufacturer Narrative
The product has been requested but not yet received.The device history was reviewed and found to meet manufacturing specifications.This investigation is ongoing.
Additional Manufacturer Narrative
The product has been requested but not yet received.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 ongoing.
Additional Manufacturer Narrative
The product was returned and evaluated.One opened bl5423wv pack from lot x7171 was returned.The expiration date on the label is 2026-apr-19.Visual inspection found the vit cutter tip protector was in place, as it should be.However, the needle was bent.The port window was in the open position with what looks like dried blood around it.The cutter tubing was dirty with fluid and what looked like blood inside the aspiration line.The back cap was 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 did not aspirate, and the inner needle did not move.The tubing fell off the back of the cutter during testing.It should be noted that loose tubing could contribute to poor cutting and aspiration.Due to the evidence of use, it could not be determined when the needle became bent or when the tubing became loose.This investigation is complete.

• Brand Name: 23GA COMBINED VITRECTOMY PACK WITH VALVES AND AFI&WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 22896304
• Report Number: 0001920664-2025-00101
• Device Sequence Number: 12258729
• Product Code: HQC
• UDI-Device Identifier: 00757770058556
• UDI-Public: (01)00757770058556(17)260419(10)X7171
• 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): 07/28/2025

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: 04/19/2026
• Device Model Number: BL5423WV
• Device Lot Number: X7171
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 09/10/2025; 10/20/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/03/2025; 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2024
• 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