MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ULTRASOUND HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number	BL3170
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in france reported that during surgery a white milky liquid was coming out of the handpiece and there was poor aspiration.There were no reported patient consequences.The pharmacist indicated that the guidelines recommend using warm distilled softened water and the establishment uses cold water (at room temperature, i.E.Around 20°c) not necessarily softened.A sterilization cycle at 134°c for 18 minutes is also recommended and the user facility does this for 18 minutes.The patient was prescribed preventative antibiotics.
Additional Manufacturer Narrative
The device has not been received for evaluation.Review of device history record, trend analysis, risk assessment, and directions for use is underway.The investigation is ongoing.
Additional Manufacturer Narrative
The device was returned and evaluated.Examination revealed that there was no visual damage.A filter test was performed by running water through the irrigation tube out onto a 0.45-micron filter, the water was then vacuumed off through the filter in an attempt to trap any possible particles.Microscopic examination of the filter found no milky white substance and no particles.A functional test was performed using a stellaris system.The handpiece data displayed tune count 9, on-time 530230 and average power 1.The handpiece tuned, primed and functioned as intended.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.The investigation is completed.

• Brand Name: STELLARIS ULTRASOUND HANDPIECE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 treecourt industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 18426419
• Report Number: 0001920664-2024-70002
• Device Sequence Number: 7697248
• Product Code: HQC
• UDI-Device Identifier: 00757770480852
• UDI-Public: (01)00757770480852(11)220809
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2023

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: BL3170
• 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: Not provided
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Unknown