MAUDE Adverse Event Report: BAUSCH + LOMB 25G STELLARIS ELITE COMBINED BI-BLADE W/ WFI; UNIT, PHACOFRAGMENTATION

Model Number SE5525WVB

Device Problem No Flow (2991)

Patient Problems Hemorrhage/Bleeding (1888); Retinal Injury (2048)

Event Type  Injury  

Manufacturer Narrative

The user facility did not retain the device or record the lot number, the device history record is unable to be reviewed.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.Additional details regarding the event are unable to be obtained as the surgeon is providing support for covid-19.

Event Description

The user facility in (b)(6) reported infusion ceased during core vitrectomy for approximately 2 minutes.There was a suprachoroidal haemorrhage and retinal break.The former provided tamponade for the latter and the patient has done well.

• Brand Name: 25G STELLARIS ELITE COMBINED BI-BLADE W/ WFI
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 9949043
• MDR Text Key: 187263236
• Report Number: 0001920664-2020-00061
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/01/2005,12/12/2019

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: SE5525WVB
• Device Catalogue Number: SE5525WVB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/27/2020
• Initial Date FDA Received: 04/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1