MAUDE Adverse Event Report: BAUSCH + LOMB MICROFLOW PHACO NDL 30DEG 6/BX; UNIT PHACOEMULSIFICATION

Model Number	DP8230S
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.This investigation is ongoing.
Event or Problem Description
The user facility in the united kingdom reported during phacoemulsificaion, a small piece of green metal appeared to come from the handpiece and had to be retrieved from the patient's eye.The particle was intact on removal and there was no harm to the patient.Site have completed their own investigation to determine the below, "after examining the phaco needle used during the procedure, i have investigated the below and as you can see with the picture (attached) above the small green piece which went into the patient¿s eye has come of the microflow needle.As you can see the microflow needle is not fully intact.The base should be a complete circle and as you can see it has small bit missing which matches the bit recovered from the patient¿s eye." photos to be attached to file.The tm provided the following information: no medical intervention, no clinical consequences, no patient impact.
Additional Manufacturer Narrative
Two green needle tips were returned in a plastic bag and were taped to a piece of gauze.Microscopic examination was performed and found one needle was damaged.A section of the hub rim had broken off.The broken piece, which was also green in color, was lying on the gauze between the two needles.The broken piece of the rim was approximately 2367 microns long by 481 microns wide.These samples will be sent to the vendor for investigation.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.
Additional Manufacturer Narrative
The vendor results indicate the most probable cause for this complaint is the needle not being fully seated onto the handpiece during installation.This investigation is closed.
Additional Manufacturer Narrative
Correction: h6 investigation findings 2 and 3.

• Brand Name: MICROFLOW PHACO NDL 30DEG 6/BX
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 6362263089
• MDR Report Key: 21675973
• Report Number: 0001920664-2025-00032
• Device Sequence Number: 8311428
• Product Code: HQC
• UDI-Device Identifier: 00757770056484
• UDI-Public: (01)00757770056484(17)290617(10)X6469
• 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,Followup,Followup,Followup
• Report Date (Section B): 03/04/2025

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 Model Number: DP8230S
• Device Lot Number: X6469
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 04/15/2025; 06/27/2025; 07/24/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 05/07/2025; 07/10/2025; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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
• Patient Sex: Unknown