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

Model Number BL15455

Device Problem Improper Flow or Infusion (2954)

Patient Problem Vitreous Loss (2142)

Event Date 02/03/2023

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation.This investigation is ongoing.

Event Description

The user facility in the united kingdom reported during a core vitrectomy, the globe suddenly collapsed.The surgeon had to stop the procedure mid-case due to no infusion.The machine failed to pump fluid during cutting of the vitreous, which caused loss of pressure and the globe to collapse.The infusion setting was on, and infusion line was intact and in place.There was no error message on the machine.

Manufacturer Narrative

Evaluation completed.Carried out routine preventative maintenance service.Checked outputs of laser, phaco, bipolar, and vitrectomy, all okay.Checked foot control functions, all okay.Carried out electrical safety test, all okay.Machine is working to specification.Final checks were all okay.Further testing carried out in user mode set-up, and combined set-up with bl5280 tubing.No issues seen.The product evaluation did not confirm the reported problem.No further actions required at this time.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.

• 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.; saint louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree ct. industrial blvd.; saint louis, MO 63122 ; 636226-322
• MDR Report Key: 17075357
• MDR Text Key: 316661559
• Report Number: 0001920664-2023-70057
• 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: 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

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 Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2018
• 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