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

Model Number	BL5110
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One collection cassette with the tubing attached was returned for evaluation, no other pack components were included.The part number and lot number cannot be verified or determined.A bottle of balanced salt solution was also returned attached to the iv spike of the pack assembly.Fluid is visible in the cassette and tubing.The fluid was poured onto a 0.45 micron filter and vacuumed off through a filter in an attempt to trap any possible particulates.Microscopic examination of the filter found large amounts of what looks like organic material.No other particles were found.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 user facility in the (b)(6) stated that during a cataract procedure, a particle was seen coming out of the irrigation port at the beginning of a case.There was no report of injury or consequences to the patient.

• Brand Name: STELLARIS VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6519874
• Report Number: 0001920664-2017-00163
• Device Sequence Number: 19029772
• Product Code: HQC
• UDI-Device Identifier: 20757770057010
• UDI-Public: (01)20757770057010(17)180312
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2018
• Device Model Number: BL5110
• Device Lot Number: V8101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1