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

Model Number BL2282

Device Problem Pressure Problem (3012)

Patient Problems Eye Injury (1845); Intraocular Pressure Increased (1937); Prolapse (2475)

Event Date 09/01/2023

Event Type  Injury  

Manufacturer Narrative

A field service engineer was dispatched to the user facility to evaluate the system.He was unable to find any faults.All function¿s of the system performed as they should.The device history was reviewed and showed the module met all specifications on the date of manufacture.The investigation is underway.

Event Description

It was reported by the user facility in the united kingdom that during the case the eye became hard due to high pressure causing the iris to prolapse.When checked the infusion pressure was set to 35mmhg.The iris was redeposited successfully and the anterior chamber reformed.Surgery was completed safely, but the iop fluctuations did compromise the corneal view to some extent making the later stages of the membrane peel more challenging.I wasn¿t timing the surgery, but the vitrectomy cutter is inefficient and the gel trimming took longer than it should have.A small volume of anesthesia top-up was needed.Apart from a slightly dilated pupil, even following miochol-e, the eye is quiet with a normal iop.

Manufacturer Narrative

The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action is required.Product evaluation did not confirm the failure and we are unable to determine the root cause.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 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; 6362263220
• MDR Report Key: 17839341
• MDR Text Key: 324530006
• Report Number: 0001920664-2023-70093
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757770497836
• UDI-Public: (01)00757770497836(17)240811
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K101325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/04/2023

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 Model Number: BL2282
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2011
• 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