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
Event or Problem Description
It was reported by a user facility in the united kingdom that a white particulate came off the left side of the phaco sleeve during the procedure, and entered the eye.The particulate was removed using forceps.Pressures and vision are very good, no discomfort or concerns.The patient was discharged back to the community optician for a routine post-cataract assessment.
Additional Manufacturer Narrative
The product and particle have been requested.The sterilization and lot history records were reviewed and found to be acceptable.Investigation is ongoing.
Additional Manufacturer Narrative
Evaluation of the returned particle was conducted.Visual examination found a light-colored particle stuck to the inside wall of a medicine cup.The cream or off-white colored particle is hard to the touch, and is approximately 911 microns long by 684 microns wide.None of the other pack components or handpiece were returned.The particle was sent for identification.The sample was analyzed using an energy-dispersive spectrometer (eds) equipped scanning electron microscope (sem).Eds analysis indicated that the sample consists primarily of carbon and oxygen.Lesser concentrations of sodium, nitrogen, chlorine, calcium, phosphorus, silicon, and potassium were also detected.This is consistent with an organic material.Pyrolysis-gas chromatography (gc/ms) was also used, and analysis indicates that the composition of the submitted sample is consistent with that of an organic material.The organic material was determined by gc/ms to be methyl methacrylate-butadiene-styrene copolymer (mbs).The root cause cannot be determined.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.Corrections to d4: from: model # bl3124s/ lot # x5204 / expiration date 30-mar-2025 / unique identifier (udi#) / (b)(4).To: model # bl5114 / lot # x5159 / expiration date 30-mar-2025 / unique identifier (udi) (b)(4).Corrections to h4: device manufacture date 30-oct-2023 to: 08-nov-2023.

• 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 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: 19216562
• Report Number: 0001920664-2024-00062
• Device Sequence Number: 15514332
• Product Code: HQC
• UDI-Device Identifier: 00757770057542
• UDI-Public: (01)00757770057542(17)260924(10)X5159
• Combination Product (Y/N): Y
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2025
• Device Model Number: BL5114
• Device Lot Number: X5159
• Was Device Available for Evaluation?: No
• 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: 06/13/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2023
• 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