MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS VACUUM PHACO PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL5111
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the user facility in the united kingdom that a patient today had white bits from the phako tip enter the eye.Pictures were provided.The particles were aspirated into the cassette.No medical intervention was reported, and the outcome was good.
Additional Manufacturer Narrative
The product has not been returned to the manufacturer for evaluation.The sterilization and lot history records were reviewed and found to be acceptable.Investigation is ongoing.
Additional Manufacturer Narrative
An evaluation of the photo provided confirms a white particle entered the eye.Although product was returned by the customer unlabeled, we cannot confirm which complaint it is for.Visual inspection of the returned samples found the assembly dirty with fluid in the lines.The balanced salt solution bottle is approximately half full.The cassette has approximately an ounce of fluid inside.Closer inspection found 3 particles/substances.One was in the connector and 2 others were in the tubing at approximately 2¿ from the connector.The fluid was drained from the collection cassette and tubing into a beaker.The fluid has a cloudy white and has the appearance of fungal growth.The fluid in the beaker was filtered through a 0.45-micron filter to trap any possible particulates.The filter was microscopically examined and found many jell-like particles/substances that had the appearance of organic matter.Two particles/substances were measured.One particle/substance is 719 x 1425 microns, and the other is 2248 x 1323 microns.The substance is soft and squishy and not hard.This sample will be sent to the lab for analysis.The investigation is ongoing.
Additional Manufacturer Narrative
The particulate was analyzed for composition using an energy-dispersive spectrometer (eds) equipped scanning electron microscope (sem).Eds analysis indicated that the sample consists primarily of carbon, oxygen, and nitrogen, with lesser concentrations of sulfur, copper, sodium, chlorine, calcium, iron, phosphorus, silicon, and potassium.This composition is consistent with an organic material.The sample was then analyzed using pyrolysis/gas-chromatography.Gc/ms analysis of the sample suggests that it is composed of glue.The analysis suggested that the submitted sample was composed of glue but could not confirm sample identity due to limitations in sample size.The tubeset was sent to the vender for evaluation.All joints on the tubeset are banded with cyclohexanone.Cyclohexanone is comprised of carbon and hydrogen only and clear in color.Investigation concluded the foreign matter is not related to the production of this tubeset and did not derive from the facility.The balanced salt solution was sent to the vendor and their investigation determined that the brown material did not derive from the bss product or its manufacturing process.The cassette assembly drawing and pack assembly work instruction were reviewed.No glue is used in the assembly of these devices.The most likely source of these particles would be from inadequate cleaning of the handpiece.Build-up inside the handpiece could result in this type of foreign matter if not cleaned thoroughly after each use.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.
Additional Manufacturer Narrative
Correction to h6 health effect impact codes from: 4645 to: 2199.

• Brand Name: STELLARIS VACUUM PHACO 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 ; 6362263089
• MDR Report Key: 20901911
• Report Number: 0001920664-2024-00152
• Device Sequence Number: 8948690
• Product Code: HQC
• UDI-Device Identifier: 00757770057092
• UDI-Public: (01)00757770057092(17)270610(10)X6438
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/13/2024

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: BL5111
• Device Lot Number: X6438
• 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: 11/15/2024
• Supplement Date Received by Manufacturer: 12/16/2024; 02/07/2025; 04/07/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/09/2025; 02/13/2025; 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT AND HANDPIECE, AND DP8230S
• Patient Sex: Unknown