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

Model Number BL15455

Device Problem No Flow (2991)

Patient Problem Eye Injury (1845)

Event Date 03/19/2024

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation.A review of the device history record found no non-conformities or anomalies related to this event.The investigation is ongoing.

Event Description

The user facility reports that the anterior chamber collapsed during segment removal due to a lack of balanced salt solution.The cornea collapsed on the phaco needle and damaged the central entopallia.The patient will need a cornea transplant.The stellaris system showed no error messages.The vacuum was set at a maximum of 450mmhg and the ultrasound power at 22%, 8 ms of burst duration, and duty cycle 1 to 75.

• Brand Name: STELLARIS ELITE VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INC.; 3365 tree ct. industrial blvd.; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 19217628
• MDR Text Key: 341458097
• Report Number: 0001920664-2024-00063
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757770524532
• UDI-Public: (01)00757770524532(11)181114
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VISCO/AMVISC COMBO, BSS, CLEARVISC