MAUDE Adverse Event Report: BAUSCH + LOMB MICROFLOW NEEDLE 30DEG.STER; 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	03/26/2025
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 the phaco needle broke in the patient's during phaco.The surgeon is a vitreoretinal surgeon and removed the shard fairly easily.There was no real delay in theatre operating time.No patient harm.
Additional Manufacturer Narrative
The product evaluation has been completed.One green needle tip was returned in an adapt¿ao +23.50 d case, lot #528128 and taped closed with no lens inside.The original packaging for the phaco needle was not returned.The part number and lot number cannot be verified or determined.The needle wrench was not returned.Visual inspection found a broken piece of a phaco needle sticking to the tape with the rest of the needle.Microscopic examination was performed and found the needle was dirty with dried solutions and particulate visible all over it.The flange on the trunk of the hub was missing material on one side, which appeared to be the returned broken piece.The broken piece of the flange was approximately 2309 microns long by 340 microns wide.The threads were marred and gouged with material missing on the same side as the broken flange.Based on signs of physical damage to the bottom of the threads, the root cause may be related to the torqueing process with the combination of the handpiece used.The sterilization and lot history records were reviewed and found to be acceptable.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.

• Brand Name: MICROFLOW NEEDLE 30DEG.STER
• 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: 21875163
• Report Number: 0001920664-2025-00054
• Device Sequence Number: 20799673
• Product Code: HQC
• UDI-Device Identifier: 00757770056484
• UDI-Public: (01)00757770056484(17)290809(10)X6745
• 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
• Report Date (Section B): 03/28/2025

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 Model Number: DP8230S
• Device Lot Number: X6745
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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