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

Model Number BL2390

Device Problem Communication or Transmission Problem (2896)

Patient Problems Corneal Edema (1791); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

After replacing the foot control, field service performed a check of the system, no anomalies were found and the system was released for use.The foot pedal was returned and evaluated; the pcb was defective and there are housing cracks.A review of the device history record was performed with no anomalies noted.The investigation is ongoing.

Event Description

The user facility in france reported during surgery the foot pedal did not respond from pitch.No error message was displayed and only four buttons worked.With the patient's eye open for four hours while the equipment was serviced.The surgeon reported there will be no patient impact.Patient outcome has been requested.

Event Description

The patient had to be operated on twice in the same day, the first time at 9:15am and the second at 3:00pm with two topical anesthesia.No side effects for patient besides stress of wait to determine the course of action.The patient had to get antibiotic coverage since the eye remained open twice in the same day with an edematous cornea which made the second surgery more complicated and more stressful for the surgeon.No surgical complications though.The patient has been seen remotely and is doing well.

Manufacturer Narrative

The root cause of the event is most probably a component issue.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.No further investigation or corrective action is necessary.

• Brand Name: STELLARIS VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 10861383
• MDR Text Key: 216885510
• Report Number: 0001920664-2020-00152
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

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: Health Professional
• Device Model Number: BL2390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STELLARIS SYSTEM AND ACCESSORIES; STELLARIS SYSTEM AND ACCESSORIES