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

Model Number BL2310

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Capsular Bag Tear (2639)

Event Date 10/18/2018

Event Type  Injury  

Manufacturer Narrative

The dhr has been reviewed and there are no anomalies.The vacuum fluidics module was evaluated and no problem was found.All values are in range.Upon visiting the user facility, the surgeon stated that she previously made no interventions with regard to adjusting bottle height or vacuum during segment removal.The settings were adjusted and after 2 cases the new settings were optimized and the surgeon reported they were "safer and more efficient".Further investigation is underway.

Event Description

The user facility in the (b)(6) had reported a fault with the machine causing an ¿anterior chamber shallowing¿ on occlusion break and extreme post occlusion surge and a dropped nucleus.

Manufacturer Narrative

Item date of report was updated to the correct product number of (b)(4).The manufacturing date was corrected to (b)(6) 2017.The root cause is unknown inconclusive as the reported problem was not duplicated during the product evaluation.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.There is no further investigation or corrective action needed at this time.The investigation is complete.

• Brand Name: STELLARIS ELITE VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman; rochester NY 14609
• MDR Report Key: 8078948
• MDR Text Key: 127404233
• Report Number: 0001920664-2018-00156
• 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,u
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL2310
• Device Catalogue Number: BL11114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: B4, H4
• Patient Sequence Number: 1