MAUDE Adverse Event Report: BAUSCH + LOMB 23G POSTERIOR PROCEDURAL PACK WITH V&WF; UNIT, PHACOFRAGMENTATION

Model Number	BL5223WV
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
Although the product was not received for evaluation, a video the hospital provided was reviewed.The video shows a 23g vitrectomy cutter in a surgical setting.The tip of the vit cutter is submerged in an unknown liquid in a metal bowl.The needle is not bent and the tubing is fully assembled while correctly attached to the cutter back cap.There is no visible damage noted on the back cap or on the aspiration barbed connector.The cutter is activated with the cut rate set to 4800 c.P.M., and the system vacuum rate is set to 450 mmhg.The cutter cannot be heard "humming" and the fluid in the bowl is not turbulent.The tubing does have fluid flowing through the aspiration line as noted in the video, but the collection cassette cannot be seen as it is behind other surgical equipment.The fluid flow into the collection cassette and the tubing connections at the stellaris system cannot be verified or determined.The cutter appears to be aspirating but not cutting or the inner needle is not advancing or moving as it should.The cause of the failure cannot be determined by viewing the video alone.The root cause of this complaint could not be determined as the complaint unit was not available for analysis at the time of this evaluation.The sterilization and lot history records were reviewed and found to be acceptable.This investigation is ongoing.
Event or Problem Description
A user facility in china reported that the vitrectomy cutter stopped working and aspiration continued.There was no patient impact.
Additional Manufacturer Narrative
The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on all available information, no causal factors can be determined and no conclusion can be drawn.

• Brand Name: 23G POSTERIOR PROCEDURAL PACK WITH V&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 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 treecourt industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 24345489
• Report Number: 0001920664-2026-00016
• Device Sequence Number: 13244494
• Product Code: HQC
• UDI-Device Identifier: 00757770058587
• UDI-Public: (01)00757770058587(17)260804(10)X7730
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2026

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: 08/04/2026
• Device Model Number: BL5223WV
• Device Lot Number: X7730
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/04/2026; 04/09/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/02/2026; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2025
• 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
• Patient Sex: Unknown