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

Model Number BL2330

Device Problem Unexpected Shutdown (4019)

Patient Problems Intraocular Pressure Increased (1937); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

A field service engineer replaced the power supply module assembly in the system on 12-aug-2020.The faulty power supply module was sent to the service depot for further evaluation.The device history was reviewed and found to meet manufacturing specifications.Additional information has been requested.The investigation is ongoing.

Event Description

A user facility in (b)(6) reported that, during surgery, phacoemulsification power was suddenly unavailable.The surgeon witnessed the system monitor screen flickering then the whole system turned off by itself.The surgeon restarted the system and received error messages usm01 "the ultrasound module was not detected in the system.Surgical mode is not available." and lm11 "the illuminator filter control has failed.".The surgery was changed to an extracapsular cataract extraction (ecce) and the surgeon was able to complete the surgery.

Manufacturer Narrative

Correction: model# bl2330; serial# (b)(6).Additional information: a field service engineer replaced the daughter board pcb assembly within the ultrasound module of the system.The error message was eliminated and the system was released for clinical use.The first day post operation, the patient developed high eye pressure and the doctor prescribed glaucoma medication.During the patient follow up visit two days later, the pressure had dropped to normal.No additional follow up could be made as the patient passed away one week after surgery due to a heart attack.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 required.The investigation is complete.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 10504602
• MDR Text Key: 217438136
• Report Number: 0001920664-2020-00103
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K101325
• 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: 01/01/2005,08/12/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: BL2330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• 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: 08/12/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention