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

Model Number	BL5325WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2016
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)(4) reported the inner needle sometimes stuck at open position so the cutter did not cut.It was replaced with a stand-alone cutter.No patient injury reported.
Additional Manufacturer Narrative
Evaluation completed.One 25ga vitrectomy cutter was returned in an unknown sterilization pouch along with a bl5325w pack label from lot v5613.The expiration date on the label is 2017-03.The tip protector was not returned.The needle was 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 pc system.The inner needle was binding up and does not enter the port window.The port remains open therefore the cutter cannot cut.It should be noted that a bent needle could contribute to poor cutting performance.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6229135
• Report Number: 0001920664-2016-00482
• Device Sequence Number: 18878272
• Product Code: HQC
• UDI-Device Identifier: 20757770058123
• UDI-Public: (01)20757770058123(17)170307
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• 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: 03/07/2017
• Device Model Number: BL5325WV
• Device Lot Number: V5613
• 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