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

Model Number BL2282

Device Problem Insufficient Information (3190)

Patient Problem Corneal Clouding/Hazing (1878)

Event Type  Injury  

Manufacturer Narrative

A review of the device history records found the module met all specifications.The investigation is ongoing.

Event Description

The user facility in (b)(6) reported that the surgeon is experiencing constant problems with the stellaris pc system.This ranges from the machine hardware to the consumables.The surgeon reported infusion failures related to ports, a poorly designed illuminated laser probe resulting in a poor surgical view, a poorly designed illuminated laser probe resulting in dislodgement of the vitrectomy port, a stellaris pc infusion failure, and a blocked infusion port.Leaking vitrectomy ports, resulting in effervescence obstructing the surgical view on repeated occasions, despite lowering of air infusion pressure.Cloudy corneas exacerbated by intraocular pressure of 40mmhg and requiring epithelial debridement as a consequence.

Manufacturer Narrative

The product was not returned for investigation, so unable to determine 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.No corrective action required.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): ST. LOUIS; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st. louis, MO 63122
• MDR Report Key: 14627017
• MDR Text Key: 293642201
• Report Number: 0001920664-2022-00084
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K101325
• 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: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL2282
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2014
• 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
• Treatment: STELLARIS AND CONSUMABLES