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

Model Number	BL5612
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.
Event or Problem Description
The user facility in (b)(6) reported the inner needle sometimes gets stuck in the open position so the cutter did not cut.It was replaced with another cutter.No patient injury reported.
Additional Manufacturer Narrative
Evaluation completed.One opened bl5612 pouch from lot v5121 was returned.The expiration date on the label is 2016-12.The tip protector was not returned.The needle was not bent.The port window was in the opened position.There was dried solution visible in the tubing.The back cap was aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected and no defects were found.A functional test was performed using a stellaris system.The cutter does not cut.The inner needle does not reach the cutting edge.

• Brand Name: STELLARIS VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6229134
• Report Number: 0001920664-2016-00481
• Device Sequence Number: 673850
• Product Code: HQC
• UDI-Device Identifier: 20757770057683
• UDI-Public: (01)20757770057683(17)161210
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2016

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: 12/10/2016
• Device Model Number: BL5612
• Device Lot Number: V5121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 02/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1