MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS PC VISION ENHANCEMENT SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number	BL5425V
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.Report 1 of 3 see 1920664-2016-00479, and 00480.
Event or Problem Description
The cutter stops working in mid stream.The surgeon has to lift up his foot from the pedal and then press it down again for the cutter to work.Additional information: the cutter is at 5000cpm when this occurs.This has been happening intermittently over time, no date of event.There has been no injury to patients and no need for medical intervention.
Additional Manufacturer Narrative
Evaluation completed.Received sealed bl5425v pack from lot v7875.The expiration date on the label is 2018-02-07.The returned sample was opened for inspection and tested.No defects were found.A functional test was performed using a stellaris pc system.The cutter had good clean cuts and had continuous cutting.The cutter did not stop during functional testing.Report 1 of 3 see 1920664-2016-00479, 00480.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6195698
• Report Number: 0001920664-2016-00478
• Device Sequence Number: 876085
• Product Code: HQC
• UDI-Device Identifier: 00757770058600
• UDI-Public: (01)00757770058600(17)180207
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2016

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: Physician
• Device Expiration Date: 02/07/2018
• Device Model Number: BL5425V
• Device Lot Number: V7875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 01/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1