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

Model Number	BL5523WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product is not available for evaluation.Sterilization and lot history records were reviewed and no exceptions were found.
Event or Problem Description
After inserting the vitrectomy cutter it does not cut however it does aspirate.

• Brand Name: STELLARIS VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6456774
• Report Number: 0001920664-2017-00141
• Device Sequence Number: 563265
• Product Code: HQC
• UDI-Device Identifier: 00757770058549
• UDI-Public: (01)00757770058549(17)180319
• 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
• Report Date (Section B): 03/14/2017

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: 03/19/2018
• Device Model Number: BL5523WV
• Device Lot Number: V8152
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2017
• Initial Report FDA Received Date: 04/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1