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

Model Number	BL5114
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Report 1 of 3.
Event or Problem Description
During phaco there were white particles present.The surgeon removed the particle from the eye with a forceps.
Additional Manufacturer Narrative
Two white colored particles were returned in a small plastic vial.The other pack components were not returned.The particles are approximately 1 mm long.They were hard to the touch.The particles were sent to the lab for analysis.The lab analyses indicate that the large white colored particles consist primarily of polycarbonate.Lesser concentrations of saline and calcium residues were also detected.

• 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: 6830724
• Report Number: 0001920664-2017-00278
• Device Sequence Number: 60334
• Product Code: HQC
• UDI-Device Identifier: 20757770057546
• UDI-Public: (01)20757770057546(17)180706
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2017

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: 07/06/2018
• Device Model Number: BL5114
• Device Lot Number: V8696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 10/22/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1