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

Model Number	BL5525WV
Medical Device Problem Codes	Kinked (1339); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in the reported event was disposed by the customer and it is not available for evaluation.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 from a user facility in the (b)(6) stated that the green irrigation tubing was kinked close to the 3 way tap, restricting the flow.There was no patient injury reported.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6539085
• Report Number: 0001920664-2017-00168
• Device Sequence Number: 19242992
• Product Code: HQC
• UDI-Device Identifier: 00757770058631
• UDI-Public: (01)00757770058631(17)180609
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/04/2017

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: 06/09/2018
• Device Model Number: BL5525WV
• Device Lot Number: V8531
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 05/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1