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

Model Number	BL5423WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2017
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 vitrectomy cutter is not cutting.No patient injury.
Additional Manufacturer Narrative
Evaluation completed.One opened bl5423wv pack from lot v8319 was returned.The expiration date on the label is 2018-04-29.Visual inspection found the vitrectomy cutter tip protector was not returned.The needle was bent.The port window was in the opened position with debris visible inside.There was dried solution all over the outer needle shaft around the port opening.A functional test was performed.The inner needle binds up and stops at approximately the center of the port.The inner needle does not reach the cutting edge and cannot cut.It should be noted that a bent needle tip could contribute to poor cutting performance.The cause of the bent needle cannot be determined.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6385398
• Report Number: 0001920664-2017-00073
• Device Sequence Number: 42411
• Product Code: HQC
• UDI-Device Identifier: 00757770058556
• UDI-Public: (01)00757770058556(17)180429
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2017

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: Physician
• Device Expiration Date: 04/29/2018
• Device Model Number: BL5423WV
• Device Lot Number: V8319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 03/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1