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

Model Number BL15455

Device Problem Inadequate User Interface (2958)

Patient Problems Vitreous Loss (2142); Capsular Bag Tear (2639)

Event Date 10/20/2021

Event Type  Injury  

Event Description

The user facility in (b)(6) reported an adverse incident due to a failure to connect their anterior vitrectomy while following the stellaris elite on-screen video.The surgery was abandoned and complications (posterior capsule rupture with vitreous loss) were managed at another hospital.It is reported that the patient has several complications with poor vision.

Manufacturer Narrative

Full training was conducted on the set up of the vitrector on (b)(6) 2021 and (b)(6) 2021 to various theatre members and the surgeon who were present on the date of the incident.This included observing them connecting the vitrector and adaptor correctly without prompt.A b+l representative attended the theatre the following morning of (b)(6) 2021 to provide further training.This investigation is ongoing.

Manufacturer Narrative

The stellaris has not been checked via field service for evaluation.We are unable to determine the root cause.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.The dhr review is complete with no anomalies noted.

Manufacturer Narrative

The end user did not follow the bl3190 instructions for use or the training that was provided by the equipment specialist to correctly connect the bl3190 adapter.The instructions for use of the bl3190 and the stellaris demonstration video were reviewed and were confirmed to be correct.

• 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 court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore
• MDR Report Key: 12814412
• MDR Text Key: 280936084
• Report Number: 0001920664-2021-00149
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2021

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
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: 12/10/2021; 03/14/2022
• Supplement Dates FDA Received: 12/21/2021; 03/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/19/2020
• 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