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

Model Number	BL5115-2
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.This investigation is ongoing.
Event or Problem Description
User facility in switzerland reported a plastic piece from the perforated sleeve hole entered the patients eye during cataract procedure.The surgeon has been able to remove this piece out of the eye.Therefore healon 5 visco was used in order to protect the anterior chamber.Prolongation of procedure: about 10-15 min.During the first report the customer could not yet estimate if this event could have caused a patient impact (for ex.Injury of the endothelia).This will be evaluated during the next appointments.The yellow deposit was asserted and will be provided to b+l.The cassette has already been discarded after procedure.
Additional Manufacturer Narrative
Complaint description was consistent with the presence of an irrigation hole punch from the yellow irrigation sleeve associated with this device.Supplier investigation found that the root cause of this issue was associated with a 2023 change in their washing process.For corrective action, the supplier returned to the previous validated washing process in 2024.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
One plastic bag was received containing two mist-yellow irrigation sleeves and a 3ml syringe.The original packaging was not received.The part number and lot number could not be verified or determined.The sleeves were dirty with particulates.Microscopic examination was performed.There was no punch out pieces remaining in the two returned sleeves.However, close inspection of the returned syringe found a light-yellow colored, disc like particle.It has the same appearance and squishy texture as the mist-yellow irrigation sleeves.The particle and sleeves were sent to the vendor for investigation.This investigation is ongoing.

• Brand Name: STELLARIS ELITE ADAPTIVE FLUIDICS STANDARD PACK
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd.; st. louis, MO ; 6362263089
• MDR Report Key: 23851768
• Report Number: 0001920664-2025-00131
• Device Sequence Number: 9571852
• Product Code: HQC
• UDI-Device Identifier: 10757770058850
• UDI-Public: (01)10757770058850(17)280111(10)X7612
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 02/16/2026

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: X7612
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/16/2026; 02/13/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/04/2026; 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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.
• Patient Sex: Unknown