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

Model Number BL2380

Device Problem No Pressure (2994)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested.The investigation is ongoing.

Event Description

A facility in (b)(6) reported that, during preparation for surgery, the stellaris system displayed error message cpx05 (the air pressure output is lower than commanded.) and no air pressure was coming from the port.The patient was an emergency retinal detachment and was already under general anesthesia.Due to the error message, the surgeon decided to cancel the surgery, woke the patient and sent them home.The delay in treatment caused by surgery cancellation can potentially cause worsening of the condition or more harm to the patient retina.No patient injury was reported.

Manufacturer Narrative

The product was not returned for evaluation.Therefore, the root cause could not be determined.The trend analysis, risk analysis, and/or directions for use review were considered acceptable with the product performing within anticipated rates.No corrective action required.

Manufacturer Narrative

The field service technician onsite repaired the stellaris compressor module by replacing the iop pump.Unfortunately, the root cause could not be determined for the reported issue.This investigation is complete.

• 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 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 treecourt industrial blvd; st. louis, MO 63122
• MDR Report Key: 12677286
• MDR Text Key: 277876041
• Report Number: 0001920664-2021-00137
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2021

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: BL2380
• Device Lot Number: 222
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 11/12/2021; 02/10/2022
• Supplement Dates FDA Received: 12/09/2021; 03/01/2022
• 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
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other