MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ELITE ADAPTIVE FLUIDICS; 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	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in the united kingdom reported that a white particle entered the patient''s eye during cataract surgery.The particle was completely removed without any clinical consequences to the patient.
Additional Manufacturer Narrative
The product is not available for return; however the foreign material is in the process of returning to the evaluation center.A review of the device history record of the first possible lot did not identify any anomalies or nonconformities that could be related to this event.The investigation of this event is in progress.
Additional Manufacturer Narrative
One specimen container pouch was returned for evaluation containing a white plastic container wrapped in an unknown green colored medical drape.Inside the container were two bright, blue pieces of foam.Microscopic examination was performed and found one fiber-like, white particle.The particle was approximately 1090 microns long by 179 microns wide.The particle was sent to the lab for further analysis.The particle was examined and photographed using a stereo-optical microscope at 32x magnification.The particle was also analyzed using an energy-dispersive spectrometer (eds) equipped scanning electron microscope (sem).Eds analysis indicated that the sample consists primarily of organic content.Lesser concentrations of chlorine, sodium, potassium, silicon, and calcium were also detected.The sample was analyzed using pyrolysis/gas-chromatography.Unfortunately, the sample size prohibited further characterization of the organic material via pyrolysis/gas-chromatography.The device history record, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.The root cause of the event could not be determined.

• Brand Name: STELLARIS ELITE ADAPTIVE FLUIDICS
• Common Device Name: UNIT, PHACOFRAGMENTATION
• 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: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 19160730
• Report Number: 0001920664-2024-00061
• Device Sequence Number: 12717067
• Product Code: HQC
• UDI-Device Identifier: 00757770057542
• UDI-Public: (01)00757770057542(17)261223(10)X5633
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2024

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
• Device Lot Number: X5633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2024
• 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