MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ELITE ADAPTIVE FLUIDICS STANDARD PACK; UNIT PHACOFRAGMENTATION

Model Number	BL5115-2
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in switzerland reported that during cataract surgery, after the nucleus had been removed, the doctor noticed a small round piece of plastic was loose in the anterior chamber of the eye.The particulate was immediately removed, and the procedure was completed without any major delay.During post-op control, there were no patient problem/incidence.The user facility reported the particulate looked to be the "lid" of one of the sleeve''s side holes.
Additional Manufacturer Narrative
The device has not been returned and the lot number was not reported.The investigation is ongoing.
Additional Manufacturer Narrative
Correction to d4 lot number from: unknown to: x4088 udi from: (b)(6).The product was returned and evaluated.Visual inspection identified one pale yellow irrigation sleeve taped to the label along with a small plastic vial containing an unknown fluid and a pale yellow disc-like particle.The particle is similar in color and shape to the port holes on the sides of the irrigation sleeve shaft at the tip.The disc-like particle is round and curled up on the edges.It would not lie flat and therefore dimensional measurements could not be taken as they would not be accurate due to the concave shape.This sample will be sent to the vendor for investigation.Manufacturing and sterilization records were reviewed and found to be acceptable.Investigation is ongoing.
Additional Manufacturer Narrative
The sample was analyzed using an energy-dispersive spectrometer (eds) equipped scanning electron microscope (sem) and the elements found were carbon, oxygen and silicon.It was also analyzed using pyrolysis/gas-chromatography, results indicated it consists primarily of polydimethylsiloxane.The vendor confirmed the findings and filed the case as a functional defect.They will continue to perform process and final quality inspections with monthly monitoring of reports.The lot history, trend analysis, risk analysis and /or directions for use review were considered acceptable, with the product performing within anticipated rates.
Additional Manufacturer Narrative
Correction to h6 investigation conclusion from 4315 to 44.

• Brand Name: STELLARIS ELITE ADAPTIVE FLUIDICS STANDARD PACK
• Common Device Name: UNIT PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 17838088
• Report Number: 0001920664-2023-70094
• Device Sequence Number: 12679287
• Product Code: HQC
• UDI-Device Identifier: 00757770058853
• UDI-Public: (01)00757770058853(17)240926(10)X4088
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170052
• 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,Followup,Followup
• Report Date (Section B): 09/11/2023

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: BL5115-2
• Device Lot Number: X4088
• 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: 09/28/2023
• Supplement Report FDA Received Date: 11/16/2023; 03/28/2024; 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2023
• 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