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

Model Number	BL3170
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in the united kingdom reported a tiny white substance/particle inside the irrigation sleeve while surgery was ongoing.There was no patient impact or medical treatment required.
Additional Manufacturer Narrative
Only the particle will be returned.The device history was reviewed and found to meet manufacturing specifications.This investigation is ongoing.
Event or Problem Description
Additional information: the particle was retrieved from the "patient's" eye using forceps.
Additional Manufacturer Narrative
The handpiece will not be returned.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.This investigation is ongoing.
Additional Manufacturer Narrative
Although the handpiece was not received for evaluation, a review of a photo provided was performed.The photo shows two glass-like slides that have two white particles between them.The slides are taped together at the bottom and top of the slides with what looks like a type of masking tape or medical tape.Handwritten on the tape:(b)(6) 2023 and handpiece.6441 lot # 00179.The two particles are encircled with what looks like a black marker.The two particles are white and semi-translucent color.The texture, size and material make-up of the particles cannot be determined by viewing the photo alone.The pack part number and lot number used with this handpiece was not noted in the complaint file.Therefore, the needle wrench style that was used in conjunction with this handpiece is unknown.A review of the bl3170 specification sheets indicate that there are no white colored components used in the manufacturing of the handpiece that would be in the irrigation flow pathway.The source and origin of particles in photo cannot be determined, unable to determine the root cause.

• Brand Name: STELLARIS ULTRASOUND HANDPIECE
• Common Device Name: UNIT PHACOEMULSIFICATION
• 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: 17217966
• Report Number: 0001920664-2023-70064
• Device Sequence Number: 19588742
• Product Code: HQC
• UDI-Device Identifier: 00757770480852
• UDI-Public: (01)00757770480852
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 06/06/2023

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
• Device Catalogue Number: BL3170
• Was Device Available for Evaluation?: No
• 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: Not provided; Not provided
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/09/2023; 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2009
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown