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

Model Number	BL5623
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in the reported event was requested for evaluation however to date it was not returned.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 (b)(6) indicated that during a procedure the cutter was cutting with delay and the cutting performance was not good.There was no report of injury or consequences to the patient.
Additional Manufacturer Narrative
One 23ga vit cutter was returned in a plastic bag.The original packaging was not returned.The part and lot number cannot be verified.Visual examination of the cutter found the tip protector missing, the needle is not bent and the port window is in the opened position.The back cap is aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected and found the air line connector damaged.It has a marred and chewed up appearance.A functional test was performed using the stellaris system.Due to the damaged connector, it was difficult to connect the air line.The cutter did not cut.The inner needle is locked up and will not advance into the port window.The cutter was re-tested using a new tubing however the inner needle did not advance into the port window.The cause of the failure cannot be determined.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6354709
• Report Number: 0001920664-2017-00069
• Device Sequence Number: 13699095
• Product Code: HQC
• UDI-Device Identifier: 20757770057911
• UDI-Public: (01)20757770057911(17)171211
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2017

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: 12/11/2017
• Device Model Number: BL5623
• Device Lot Number: V7358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/26/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 06/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1