MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS I/A HANDPIECE SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number	BL3160
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility in france reported that particulates were detected during surgery.The particulates entered the patient eye and were removed.There was no patient impact.
Additional Manufacturer Narrative
The initial report was submitted on 27mar2024 under incorrect cfn/fei/hcfa id (1313525) core id (b)(4).(b)(4).Resubmitting initial report under correct cfn/fei/hcfa id (1920664) the device was returned and found to be dented on the rim.There is a fiber-like particle inside the tip insertion area of the handpiece.There are particles visible in the irrigation tube at the back of the handpiece as well.The investigation is ongoing.
Additional Manufacturer Narrative
It was confirmed the lot was shipped to the distributor in 2010, photos show normal wear and tear for a 14 year old device.Batch record review could not be completed due to the age of the device.A review of the trend and risk analysis were reviewed and considered acceptable with the product performing within anticipated rates.The investigation is complete.

• Brand Name: STELLARIS I/A HANDPIECE SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY; 8415 154th avenue; redmond WA 98052
• Manufacturer Contact: juli moore ; 3365 treecourt industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 19138666
• Report Number: 0001920664-2024-00058
• Device Sequence Number: 9420685
• Product Code: HQC
• UDI-Device Identifier: 00757770483488
• UDI-Public: (01)00757770483488(10)036396
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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 Model Number: BL3160
• Device Lot Number: 036396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• 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: 04/18/2024
• Supplement Report FDA Received Date: 06/27/2024
• 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 Sex: Unknown