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

Model Number BL2363

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

Visual inspection of the returned device found extensive physical damage to the unit had occurred.Several components appear to have been damaged by salt action rendering them no longer reliable in operation.A review of the manufacturing records confirmed this unit met all specifications at the time of release.Additional investigation results are pending.

Event Description

User facility experienced system shutdown during surgery.The system came back on during a different interval.No patient injury was reported.

Manufacturer Narrative

The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action was deemed necessary.This unit was in an extremely poor state upon return.The on/off pcb had been damaged by salt action and was no longer reliable in its operation.At a minimum, several cover items are in need of replacement.The assembly reflects a previous service date of december 2015.Based on the product evaluation results, the most probable root cause is lack of service/maintenance.The investigation is complete.

• Brand Name: STELLARIS VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB INC; 1400 n goodman st; rochester NY 14609
• MDR Report Key: 8606126
• MDR Text Key: 144983768
• Report Number: 0001920664-2019-00079
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2019

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
• Device Operator: Health Professional
• Device Model Number: BL2363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1