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

Model Number BL15455

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Eye Injury (1845); Inflammation (1932); Vitrectomy (2643)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

The root cause of the event is unknown has the user facility as eliminated the stellaris system as a potential source of contamination.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No further investigation or corrective action is necessary.

Event Description

The user facility in france reported a patient experienced toxic anterior segment syndrome (tass), the same day after having anterior surgery with a diagnostic vitrectomy and anterior chamber puncture, involving the stellaris elite pc.The healthcare facility eliminated the stellaris system as a potential cause of the event after a bausch & lomb sales representative explained the mechanisms of the system.Visual acuity as of (b)(6) 2020 was 1/10.The patient presented with good evolution and left the hospital.Initially thought to be endophthalmitis, bacteriological testing performed was negative.

Manufacturer Narrative

Additional information received, the patient had gradual decrease in inflammation and corneal edema.Patient's visual acuity one month post procedure 5/10 p2, persistence of minimal corneal edema.No tyndall or hyalitis.Anti-inflammatory treatment was decreased.The investigation is complete.

• Brand Name: STELLARIS ELITE VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 10477157
• MDR Text Key: 205342859
• Report Number: 0001920664-2020-00100
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/03/2020

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: BL15455
• Device Catalogue Number: BL15455
• 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: 08/03/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BL5115-3 LOT W5075, ALCON BSS,PHACO PACK AND KNIFE
• Patient Outcome(s): Required Intervention