MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED 23GA STELLARIS ELITE POSTERIOR WF; UNIT, PHACOFRAGMENTATION

Model Number SE5423WV

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2021

Event Type  malfunction  

Event Description

The vitrectomy handpiece 23 gauge leaked from the cutter drive line.A cutter replacement was used to continue the case.

• Brand Name: 23GA STELLARIS ELITE POSTERIOR WF
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED; 100 research drive; wilmington MA 01887
• MDR Report Key: 11782811
• MDR Text Key: 249231403
• Report Number: 11782811
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SE5423WV
• Device Catalogue Number: SE5423WV
• Device Lot Number: W8756
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA