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

Model Number	BL5112
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One opened bl5112 pack from lot v7558 was returned for evaluation.Visual examination found fluid on the lines.A functional test was performed using a stellaris pc system.The collection cassette was captured and recognized.The assembly passed the self vacuum test, primed, irrigated and aspirated as intended.The drip chamber and line did not lose fluid and remained filled during the functional testing.We were unable to reproduce the reported failure.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 health facility in (b)(6) stated that after the calibration of the system and after pressing the irrigation dropper, the irrigation line does not maintain the saline solution and it turns empty.This creates some air bubbles that are introduced into the posterior chamber of the eye.A new pack was used to continue with the surgery.There was no impact or injury to the patient.The patient is fine.

• Brand Name: STELLARIS VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6555393
• Report Number: 0001920664-2017-00193
• Device Sequence Number: 13697705
• Product Code: HQC
• UDI-Device Identifier: 10757770057082
• UDI-Public: (01)10757770057082(17)180118
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 04/10/2017

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: Health Professional
• Device Expiration Date: 01/18/2018
• Device Model Number: BL5112
• Device Lot Number: V7558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2017
• Initial Report FDA Received Date: 05/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1