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 Inflammation (1932); Vitrectomy (2643)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

The root cause of the event is unknown as the user facility has 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 (b)(6) reported a patient experienced toxic anterior segment syndrome (tass) after having cataract surgery involving a 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.Post-op day 1: the patient had a painful red eye and visual acuity was moving hand.Emergency diagnostic vitrectomy, anterior chamber puncture and intravenous injection of vancomycin and fortum (ceftazidime).At 48 hours: new anterior chamber puncture and interruption antibio + injection of actilyse in the anterior chamber.Occurrence of a significant intravitreal hemorrhage on (b)(6) 2020 after the completion of the second series of intravenous injection with antibiotic.Gradual resorption of intravitreal bleeding.Visual acuity at 3/10 weak on (b)(6) 2020, persistence of descemet folds, tyndall 1+, presence of haematic deposits behind the implant, minimal intravitreal hemorrhage.Decreasing of anti-inflammatory treatment.Initially thought to be endophthalmitis, bacteriological testing performed was negative.

• Brand Name: STELLARIS ELITE VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 10503445
• MDR Text Key: 206108572
• Report Number: 0001920664-2020-00104
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/01/2005,08/13/2020

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: 08/13/2020
• Initial Date FDA Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention