MAUDE Adverse Event Report: BAUSCH + LOMB MICROFLOW NDL 30 DEG STERILE; UNIT PHACOEMULSIFICATION

Model Number	DP8230S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility in the united kingdom reported that the surgeon found a sharp fragment of phaco needle coming out from the handpiece when performing phaco during cataract surgery.It was identified as a broken part of the phaco needle.The surgeon filled the eye cavity with eyefill hd and removed the fragment carefully from the eye.No extra medications prescribed to the patient apart from the standard discharge drops.Surgeon confirmed the fragment had been removed from the eye safely and the impact to the patient was minimal.The product has been discarded.
Additional Manufacturer Narrative
The device has been discarded and cannot be returned for evaluation.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 root cause of this complaint could not be determined as the complaint unit was not available for analysis.The investigation is complete.
Additional Manufacturer Narrative
Although the product has not been received for evaluation, a review of the photos attached to the complaint file was performed.The one photo shows an opened dp8230s pouch from lot x8311.Another photo shows a green phaco needle being held by gloved fingertips.It is clear by this photo that a section of the hub rim is broken off and missing.The next photos show a green colored particle in a half-moon or semi-circle shape, in the patient's eye.The particle is similar in appearance to the color of the needle and similar in shape to the missing broken rim section on the needle hub.Further review also noted damage or gouges on the threads of the needle as well.The rest of the needle is not visible in the photos.It cannot be determined if the shaft or tip is damaged.The cause of the broken rim section and the damaged needle threads cannot be determined by viewing the photo alone.The investigation is complete.

• Brand Name: MICROFLOW NDL 30 DEG STERILE
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 24270059
• Report Number: 0001920664-2026-00014
• Device Sequence Number: 10059094
• Product Code: HQC
• UDI-Device Identifier: 00757770056484
• UDI-Public: (01)00757770056484(17)280608(10)X8311
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DP8230S
• Device Lot Number: X8311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 01/13/2026; 05/06/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 02/09/2026; 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown