MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ELITE ADAPTIVE FLUIDICS BASIC PACK; 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	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility in the united kingdom reported that during anterior cataract surgery with bl5114, at point of initial sculpt with the phaco handpiece and mics needle, the consultant noticed a piece of debris floating in the eye (likely from the infusion line - suspected to be a piece of bung from the bottle).There was a slight delay in operation of 2 minutes while extra viscoelastic injected into eye and debris removed with forceps.
Additional Manufacturer Narrative
The sample is being returned for evaluation.The investigation of this event is ongoing.
Additional Manufacturer Narrative
One bss-10pk bottle of balanced salt solution was returned along with an iv spike, drip chamber, about 2 inches of irrigation tubing along with a small plastic vial.The vial contained a cream -colored particle.The bottle contained 125 ml of solution.The iv spike was dirty with dried solutions visible in the tubing and drip chamber.The tip of the iv spike was blunted and appears to have been used.The rest of the pack assembly was not returned.The cream-colored particle is similar in color to the bss bottle septum.The particle is soft and squishy, not hard.Microscopic examination of the septum on the bss bottle found that there is material missing from the septum.The particle, and the bss was sent to the vendor for investigation.A review of the device history record found no nonconformities or anomalies related to this complaint.The investigation of this event is ongoing.
Additional Manufacturer Narrative
The evaluation confirmed that the fm/particulate was tpe (thermoplastic elastomer) which was part of the bss bottle's twin port cap.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.The investigation is complete.

• Brand Name: STELLARIS ELITE ADAPTIVE FLUIDICS BASIC PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 18996173
• Report Number: 0001920664-2024-00048
• Device Sequence Number: 3089308
• Product Code: HQC
• UDI-Device Identifier: 20757770057546
• UDI-Public: (01)20757770057546(17)250617
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2024

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 Expiration Date: 09/30/2026
• Device Model Number: BL5114
• Device Lot Number: X5193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/21/2024; 06/25/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 06/17/2024; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Female