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)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been discarded and the lot number is unknown.Therefore a review of the device history record cannot be performed.The investigation is ongoing.
Event or Problem Description
The user facility in the united kingdom reports that an unknown particle went into patient''s eye during surgery.The surgeon used the vacuum from the phaco handpiece to remove the particle.They set up new tubing and they were able to finish the case successfully.No patient impact.No medical intervention.
Additional Manufacturer Narrative
We are unable to investigate further for root cause.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.
Additional Manufacturer Narrative
One blue irrigation sleeve was returned in a small plastic vial and the rest of the pack components and the original packaging were not returned.The part number and lot number could not be verified or determined.The sleeve was dirty with particulates and dried solutions all over.Microscopic examination found the tip is inverted or turned down inside.There were white colored particles visible in the folds of the tip.When attempting to remove the particles, most broke apart into very tiny, powder, or dust-like particles.One particle was retrieved from the tip.The particle is hard to the touch.It is 439 microns long by 202 microns wide.Due to evidence of use, the source and origin of the white particle cannot be determined.The investigation is complete.
Additional Manufacturer Narrative
Udi related data quality updates only.The udi-di is being provided.Although requested, the lot number was not provided, therefore the udi-pi is not available.

• Brand Name: STELLARIS PHACO PREMIUM PACK WITH MICS NEEDLE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 18356008
• Report Number: 0001920664-2023-70139
• Device Sequence Number: 20568950
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/28/2023

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
• 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; Not provided; Not provided
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/16/2024; 02/20/2024; 10/05/2024
• Was Device Evaluated by Manufacturer? (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 SYSTEM AND ACCESSORIES
• Patient Sex: Unknown