MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS PHACO PREMIUM PACK WITH MICS NEEDLE; UNIT, PHACOFRAGMENTATION

Model Number	BL5114
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not able to be returned and the lot number is unknown.Therefore a review of the device history record cannot be performed.Review of trend analysis, risk assessment, and directions for use is underway.The investigation is ongoing.
Event or Problem Description
A user facility in the united kingdom reported that an a small part of the purple tip ended up in the patients eye.The particle was removed and there was no patient harm.
Additional Manufacturer Narrative
A purple needle and a purple particle were returned, the part number and lot number could not be verified or determined.Visual inspection found that there is a scratch visible on the hub of the needle.One metallic looking particle that is purple in color was found in the weave of a piece of gauze.The particle is approximately 506 microns wide by 2344 microns long.Microscopic examination of the needle found no missing material, the source and origin of the particle are unknown.This needle and the particle will be sent for further evaluation.The device history records, trend and risk analysis were reviewed and considered acceptable with the product performing within anticipated rates.The investigation is ongoing.
Additional Manufacturer Narrative
The needle was sent for further evaluation and found there was no significant damage or missing material.The needle underwent 100% visual inspection prior to shipment.The device lot number is unknown, therefore a review of the device history record cannot be performed.The trend and risk analysis were reviewed and considered acceptable with the product performing within anticipated rates.The investigation is complete.

• Brand Name: STELLARIS PHACO PREMIUM PACK WITH MICS NEEDLE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 treecourt industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 18426857
• Report Number: 0001920664-2024-70003
• Device Sequence Number: 18066738
• Product Code: HQC
• UDI-Device Identifier: 00757770057542
• UDI-Public: (01)00757770057542
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2023

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: BL5114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 04/24/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 02/06/2024; 05/22/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS SYSTEM AND ACCESSORIES
• Patient Sex: Unknown