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

Model Number BL12110

Device Problem Increase in Suction (1604)

Patient Problem No Code Available (3191)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

A serial number was not provided; therefore, the device history records could not be reviewed.Further investigation underway.

Event Description

The user facility in the (b)(6) reported during surgery the intraocular lens moved to the back of the eye due to the high suction of the stellaris.Procedure was ended, and the patient was moved to an academic hospital.

Manufacturer Narrative

The product serial number is unknown, and the product is not available for evaluation; therefore, the investigation is complete.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: STELLARIS VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 8907448
• MDR Text Key: 155031019
• Report Number: 0001920664-2019-00171
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BL12110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention