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

Model Number BL5114A

Device Problems Inability to Irrigate (1337); Kinked (1339); Device Damaged Prior to Use (2284)

Patient Problem No Information (3190)

Event Date 02/25/2016

Event Type  Injury  

Manufacturer Narrative

Product has been requested for evaluation however it has not yet been received.

Event Description

The tubing was kinked.Continued with surgery however during viscoelastic removal the irrigation stopped.The patient required further surgery with a vitreoretinal surgeon.

Manufacturer Narrative

One collection cassette and tubing were returned wrapped up in a plastic bag.The tubing was wadded and partially wrapped around the cassette.Visual inspection found the assembly dirty with fluid in the lines.Closer inspection found the irrigation line kinked at the tubing manifold base.A functional test was performed using a stellaris pc system.The assembly display reduced irrigation.Due to the conditions in which the product was returned, the cause of the kinded tubing cannot be determined.The lot number of the device used in the event is unknown; therefore, a review of the lot manufacturing records cannot be performed.Based on all information, no causal factors can be determined and no conclusion can be drawn.

• Brand Name: STELLARIS VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): ST. LOUIS; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: sharon spencer ; 50 technology drive west; irvine, CA 92618
• MDR Report Key: 5535007
• MDR Text Key: 41457690
• Report Number: 0001920664-2016-00138
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL5114A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1