MAUDE Adverse Event Report: BAUSCH + LOMB MICRO-COAXIAL 2.0 PHACO NEEDLE, ANGLED; UNIT PHACOFRAGMENTATION

Model Number	BL3420S
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility in australia reported that the surgeon thought he saw something come from the tip or handpiece into the patient''s eye.The fragment was no longer visible.The needle and handpiece were changed and a new sleeve was applied to the phaco tip.The new handpiece tuned and the surgery was completed without further incident.The needle and sleeve are not available for return.
Additional Manufacturer Narrative
A lot number was not provided; therefore, the sterilization and lot history records could not be reviewed.This investigation is ongoing.
Additional Manufacturer Narrative
The product or the particle were not returned for investigation.The 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 investigation is complete.

• Brand Name: MICRO-COAXIAL 2.0 PHACO NEEDLE, ANGLED
• Common Device Name: UNIT PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 17861970
• Report Number: 0001920664-2023-70101
• Device Sequence Number: 12295931
• Product Code: HQC
• UDI-Device Identifier: 10757770058713
• UDI-Public: 10757770058713
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063331
• 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
• Report Date (Section B): 09/07/2023

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: BL3420S
• Device Lot Number: UNKNOWN
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT, BL5115/4, DP5531
• Patient Sex: Unknown