MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS PHACO PREMIUM PACK WITH MICS NEEDLE; UNIT, PHACOFRAGMENTATION

Model Number	BL5114
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded and is not available for evaluation.The device history records were reviewed and found manufacturing and sterilization records to be acceptable.The investigation is ongoing.
Event or Problem Description
The user facility in the (b)(6) reported a black particle appeared in the patient's eye during the sculpting phase.The particle was removed and the surgery was prolonged for 10 minutes.There was no impact to the patient.
Additional Manufacturer Narrative
The customer discarded the particle, so unable to investigate the root cause.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 is required.The investigation is complete.
Additional Manufacturer Narrative
It was previously reported that the device and particle were discarded.Both were found and have been returned.The evaluation was completed.One collection cassette with tubing was returned in a plastic bag along with a small plastic vial.The part number and lot number cannot be verified or determined.The assembly was dirty with fluid in the lines and a small amount in the collection cassette.Some of the fluid had leaked out and is all over the assembly.Visual inspection found no dark-colored particles visible in the bag, cassette, or tubing.A functional test was performed using a stellaris pc system.The collection cassette was captured and recognized by the system.The assembly passed the self-vacuum test, primed, irrigated, and aspirated as intended.The assembly was not blocked or clogged.The balanced salt solution (bss) bottle was not returned.However, the sample bss bottle used during functional testing did not collapse during testing.The small plastic vial was microscopically inspected.There were no black or dark-colored particles visible in the vial.There was a white-ish-colored particle in the vial.The particle was hard to the touch and was approximately 660 microns by 755 microns in size.There were a couple of dark-colored areas visible on the particle itself.The particle was sent to a laboratory for analysis.The white-colored particle was analyzed using an energy dispersive spectrometer (eds).The results indicate that it consists primarily of calcium and oxygen.Lesser concentrations of phosphorus, carbon, sodium, silicon, chlorine, magnesium, and aluminum were also detected.This is consistent with calcium phosphate with lesser concentrations of saline residue and mineral deposits.The source and origin of the particle cannot be determined.Therefore, the root cause cannot be determined.The device history record was reviewed and found to be acceptable.The lot history, trend analysis, risk analysis, and directions for use review were considered acceptable, with the product performing within anticipated rates.The investigation is complete.

• Brand Name: STELLARIS PHACO PREMIUM PACK WITH MICS NEEDLE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 11879717
• Report Number: 0001920664-2021-00066
• Device Sequence Number: 11652640
• Product Code: HQC
• UDI-Device Identifier: 00757770057542
• UDI-Public: (01)00757770057542(17)210803(10)W6679
• Combination Product (Y/N): Y
• 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): Y
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2021
• Device Model Number: BL5114
• Device Catalogue Number: BL5114
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 06/10/2021; 07/20/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/24/2021; 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALANCED SALT (BSS)