MAUDE Adverse Event Report: BAUSCH + LOMB, INC STELLARIS COMPRESSOR MODULE A; UNIT, PHACOFRAGMENTATION

Model Number BL2282

Device Problems Suction Problem (2170); Improper Flow or Infusion (2954)

Patient Problem Intraocular Pressure Increased (1937)

Event Date 10/26/2022

Event Type  Injury  

Event Description

A user facility in the united kingdom reports that post operatively, three patients from the list had high iop and had to see a glaucoma specialist.Of the three, one patient had glaucoma surgery.This is related to the patient having glaucoma surgery.The surgeon also commented that the machine was refluxing, no issues from the flow dynamics, other than a leakage of fluid onto the floor at then end of the cases.All viscoelastic was removed and they were second eyes - no problem with the first eyes operation.They are wondering if the aspiration was not functioning adequately so that some visco was left or that the inflow tube allowed fluid other than bss to enter the eye.

Manufacturer Narrative

Rather than have the device returned, a technician was dispatched to the site to evaluate the system.The system was functioning normally and the reported problem was not reproducible.The condensation drain filter had moisture in it.The condensation drain filter was checked for function.The float is intact and drains the excess moisture as needed.All values are in the specified range.The device history record was reviewed and showed the device met specifications on the date of manufacture.The investigation is underway.

Manufacturer Narrative

The reported problem was not duplicated.The root cause is unable to be determined.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.No further actions required at this time, will continue to monitor complaints of this nature.The investigation is complete.

Event Description

A user facility in the united kingdom reports that post operatively, one patient had to see a glaucoma specialist and subsequently have glaucoma surgery.

• Brand Name: STELLARIS COMPRESSOR MODULE A
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC; 1400 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 16287298
• MDR Text Key: 308679923
• Report Number: 0001920664-2023-00009
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757770524495
• UDI-Public: (01)00757770524495(11)190305
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL2282
• Device Catalogue Number: BL11145
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2019
• 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 SYSTEM AND ACCESSORIES