MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS PHACO PACK WITH MICS NEEDLE; UNIT, PHACOFRAGMENTATION

Model Number	BL5113
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.Manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is ongoing.
Event or Problem Description
It was reported by the user facility in italy that during the surgery, at the end of phase irrigation/aspiration, when the instrument was removed, the tip broke and a part of it remained inside the eye.It was removed with care and without complications.
Additional Manufacturer Narrative
Evaluation of the returned product through microscopic examination found the sleeve is dirty with particulates all over.There is a tear and gouges visible on the inside of the sleeve near the hub with material missing.In addition, the tip of the sleeve is torn off at the hub and is missing.The torn piece was not returned.The damage (gouges and missing material) found at the hub of the sleeve is likely damage caused by the phaco needle tip when not inserted properly in the sleeve, thereby slicing off slivers of the sleeve as it is put onto the needle tip.The most probable root cause was determined to be user error.The lot history, trend analysis and direction for use review were considered acceptable, with the product performing with anticipated rates.No corrective action is required.

• Brand Name: STELLARIS PHACO PACK WITH MICS NEEDLE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 22336404
• Report Number: 0001920664-2025-00080
• Device Sequence Number: 9060751
• Product Code: HQC
• UDI-Device Identifier: 00757770057238
• UDI-Public: (01)00757770057238(17)271208(10)X7391
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: BL5113
• Device Lot Number: X7391
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT AND ACCESSORIES
• Patient Sex: Unknown