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

Model Number BL15455

Device Problems Use of Incorrect Control/Treatment Settings (1126); Use of Device Problem (1670)

Patient Problem Capsular Bag Tear (2639)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

The system was inspected at the site by a bausch + lomb representative.The system was found to function within specification with no faults found.A review of the manufacturing records found the system met all specification at the time of release.It was determined the machine settings used during the procedure were incorrect.The surgeon has been advised of the correct machine settings.

Event Description

A report received from a user facility in the (b)(4) stated that according to the surgeon, the phaco phase in the stellaris elite foot control settings is activated too early which caused the surgeon to inadvertently phaco the capsular bag.Additional information regarding patient outcome has been requested.

Manufacturer Narrative

We have contacted the hospital several times for an update on the patient's conditions; however, no updates were provided.A follow-up visit was set up by our territory manager to verify the unit performance.The review indicated that the problem was associated to the incorrect surgeon setting for the foot control with serial number (b)(4).

• Brand Name: STELLARIS ELITE VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7689743
• MDR Text Key: 114033843
• Report Number: 0001920664-2018-00084
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL15455
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other