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

Model Number BL3170

Device Problem Particulates (1451)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

Multiple requests have been made to procure additional information, device and particulate return.The investigation is ongoing.

Event Description

The user facility in the (b)(6) reported a particle came out of the phaco handpiece.No medical intervention or patient impact reported.Requests sent for patient contact.

Manufacturer Narrative

The device has not been returned for evaluation.However, three particles were returned.The particles were cloudy white and semi-translucent in color and are hard to the touch.The first particle is approximately 2000 microns by 408 microns, the second particle is approximately 1050 by 320 microns and the third particle is approximately 1126 by 409 microns in size.The particles were sent to the lab for analysis.The white particles were analyzed using an energy dispersive spectrometer (eds).The results indicated that it consists primarily of carbon and oxygen.Lesser concentrations of sodium, silicon, phosphorus, calcium, aluminum, chlorine, and potassium were also detected.This is consistent with organic material, saline residue, and mineral deposits.The white particles were analyzed using a fourier transform infrared (ftir) spectrometer.The ftir analysis of the white particle produced a spectrum consistent with that of polycarbonate.These materials are not used in the manufacture of the bl3170 handpiece.The product evaluation confirmed the existence of the white particle.However, the source of this particle is not from the bl3170 handpiece based on the lab analysis of the returned white particles.The actual source is unknown.The investigation is complete.

Manufacturer Narrative

The device nor foreign matter has been returned for evaluation.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Further investigation will be performed upon receipt of additional information or device return.

• Brand Name: STELLARIS ULTRASOUND HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 11378642
• MDR Text Key: 233765923
• Report Number: 0001920664-2021-00018
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL3170
• Device Catalogue Number: BL3170
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STELLARIS SYSTEM AND ACCESSORIES.