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

Model Number	BL5420W
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in the reported event was not returned for evaluation therefore we are unable to determine the root cause of the problem.The lot/device manufacturing records were reviewed and found to be acceptable.Based on all information, no causal factors can be determined and no conclusion can be drawn.
Event or Problem Description
A report received from a healthcare professional in (b)(6) indicated that the vit cutter did not cut correctly during the procedure.There was no report of injury or consequences to the patient.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6341247
• Report Number: 0001920664-2017-00063
• Device Sequence Number: 13855707
• Product Code: HQC
• UDI-Device Identifier: 20757770058130
• UDI-Public: (01)20757770058130(17)170321
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2017

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: 03/21/2017
• Device Model Number: BL5420W
• Device Lot Number: V5690
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2017
• Initial Report FDA Received Date: 02/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1