MAUDE Adverse Event Report: BAUSCH + LOMB ADAPTIVE FLUIDICS MICS PREMIUM PACKS; UNIT PHACOFRAGMENTATION

Model Number BL5115-3

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

The user facility in the netherlands reported during the sculpt portions of cataract surgery some blue/white fibers appeared in the anterior chamber, as well as a metal particle.

Manufacturer Narrative

Though requested the particulate sample has not been returned for evaluation at this time.A lot number was not provided; therefore, the sterilization and lot history records could not be reviewed.

Manufacturer Narrative

The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.

Manufacturer Narrative

The particles were microscopically examined, and measured using a camera equipped optical stereo microscope.One particle exhibited a fragile, blue appearance while the other exhibited a metallic appearance.The particles were also analyzed using an energy dispersive spectrometer (eds) equipped with a scanning electron microscope (sem).Eds analysis of the blue particle indicated that it consisted primarily of carbon, chlorine, and sodium.Lesser concentrations of oxygen, silicon, phosphorus, and magnesium were also detected.This is consistent with salt and organic material.Eds analysis of the metallic particle indicated that it consists primarily of titanium.Lesser concentrations of aluminum and vanadium were also detected.This is consistent with titanium alloy.We are unable to definitively identify the source of the particles.

Manufacturer Narrative

A visual inspection was completed.One opened bl5115-3 combined dpi tube with stable chamber tray was returned.Visual inspection found the tubing was tangled and loosely packed with an empty bss bottle.No other content was returned.The lot number and expiration date is unknown.Under microscopic visual inspection found a bluish feathery type material, along with a darker particle that appeared to be a harder substance.The particulate will be sent to a testing lab for further results.

• Brand Name: ADAPTIVE FLUIDICS MICS PREMIUM PACKS
• Type of Device: UNIT PHACOFRAGMENTATION
• 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 ; 3365 tree court industrial blv; st. louis, MO 63122
• MDR Report Key: 12984347
• MDR Text Key: 283409421
• Report Number: 0001920664-2021-00158
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/18/2021

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
• Device Model Number: BL5115-3
• Device Catalogue Number: BL5115-3
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 01/03/2022; 01/31/2022; 02/24/2022
• Supplement Dates FDA Received: 01/25/2022; 02/22/2022; 03/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STELLARIS UNIT.