MAUDE Adverse Event Report: BAUSCH + LOMB MICROFLOW 2.2 30 DEG NEEDLE; UNIT PHACOEMULSIFICATION

Model Number	DP8730S
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the product has not been received for evaluation, a review of the photo attached to the complaint file was performed.The product packaging was not visible in the photo.The part number, lot number and expiration date could not be verified or determined.The photo showed a sliver particulate in or on the center of the eye (pupil area).The particle has a metallic appearance.The ultrasound handpiece and the phaco needle tip were not returned.The source and origin of the metallic-like sliver could not be determined.A device history record review was performed.This system met specifications on the date of manufacture.This investigation is ongoing.
Event or Problem Description
The user facility in germany reported that during the procedure and after phaco, a metal deposit was noticed in the patient's eye.It was removed with forceps and discarded.There was no patient impact.The procedure was prolonged by approximately two minutes and there was no additional anesthesia usage.
Additional Manufacturer Narrative
The product was returned for evaluation.The ultrasound handpiece, needle wrench, and instruction sheet were not returned.One blue/teal needle tip was returned inside an unknown sterilized pouch.The part number and lot number could not be verified or determined.The silver particle shown in the photo provided was not returned.Visual inspection found the needle was dirty with particulates all over.Microscopic examination found the blue/teal anodized coloring had faded or had been removed near the tip of the needle.The needle was damaged.The threads of the hub had visible damage.The damage to the hub was consistent with damage seen when the needle is over-tightened.This could contribute to particulate generation during use.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.The most probable cause was determined to be surgical technique.No corrective action is required.This investigation is complete.

• Brand Name: MICROFLOW 2.2 30 DEG NEEDLE
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INC.; 3365 tree ct. industrial blvd.; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree ct. industrial blvd.; st. louis, MO ; 6362263089
• MDR Report Key: 22287309
• Report Number: 0001920664-2025-00082
• Device Sequence Number: 15676816
• Product Code: HQC
• UDI-Device Identifier: 00757770057252
• UDI-Public: (01)00757770057252(17)290817(10)X6795
• 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): 05/26/2025

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: DP8730S
• Device Lot Number: X6795
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/22/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown