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

Model Number BL2363

Device Problem Mechanical Jam (2983)

Patient Problem Capsular Bag Tear (2639)

Event Date 06/30/2022

Event Type  Injury  

Event Description

The user facility reported that the iv pole got stuck going up when using bss by gravity.The eye collapsed and capsule ruptured during cataract surgery in segment mode.Procedure was prolonged maybe 10-15 minutes as an unplanned vitrectomy was needed.No additional anesthesia was required.Surgeon was able to install lens and patient outcome was good.

Manufacturer Narrative

Field service reported the issue was not duplicated during their service visit on (b)(6) 2022.The iv pole controller and the uic were replaced as a precaution and have been sent back for evaluation, but not yet received.Investigation is ongoing.

Manufacturer Narrative

B4.Model # bl2340 serial # (b)(6) corrected to model # bl2363 serial # (b)(6).This system previously had a failure where the iv pole stopped moving.The problem was not duplicated but the iv pole was replaced as a preventative measure.The system recently had another failure whereby the iv pole stuck going up using bss by gravity.System appeared to operate normally after a hard reset.The issue was not duplicated during the service visit.Since the iv pole was previously replaced, then the other component most likely responsible for this issue is the iv pole controller or the user interface computer which drives the iv controller.The iv pole controller and the uic were replaced as a preventative measure.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 computer module was returned for evaluation and confirmed the reported problem could not be duplicated.The root cause cannot be determined.

• Brand Name: STELLARIS VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 15054317
• MDR Text Key: 296158249
• Report Number: 0001920664-2022-00097
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL2363
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention