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

Model Number BL2330

Device Problem Increase in Pressure (1491)

Patient Problems Eye Injury (1845); Capsular Bag Tear (2639)

Event Date 05/05/2021

Event Type  Injury  

Manufacturer Narrative

The device history was reviewed and found to meet manufacturing specification.This investigation is ongoing.

Event Description

The user facility initially reported too much power through hand piece that caused torn capsule in the eye.Additional information from the surgeon: the doctor reported an irrigation aspiration issue.Patient underwent a mechanical vitrectomy, the posterior iol was removed, and an anterior lens implanted.Five day post-op the patient's vision is improving; however the doctor referred the patient to a retina specialist.

Manufacturer Narrative

Field service was on site and found the iop port was loose.The iop port assembly was replaced.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.

Manufacturer Narrative

The module was tested and verified the phaco output by running the phaco function for 30 seconds at 50% 50 times and at 100% power 50 times.We monitored the power output for a spike exceeding the maximum acceptance specification of 21 watts and 42 watts.The power output stayed consistently at an average of 18 watts at 50% and 35 watts at 100%.The average was consistent with anterior modules tested at the service depot.Usm06770 has no complaint or repair history with the service department.The device history was reviewed and found to meet manufacturing specification.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.

Event Description

Additional information: the doctor reported an irrigation aspiration issue.The sales rep worked with the doctor and believes the issue is with a lose iop port.

• Brand Name: STELLARIS VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 3365 tree court industrial blv; rochester NY 14609
• MDR Report Key: 11897753
• MDR Text Key: 253223292
• Report Number: 0001920664-2021-00062
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757777052449
• UDI-Public: 01007577770524495
• Combination Product (y/n): Y
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2021

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: BL2330
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 06/16/2021; 09/28/2021
• Supplement Dates FDA Received: 07/07/2021; 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention