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

Device Problems Air Leak (1008); Peeled/Delaminated (1454); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

A female patient was to undergo a pars plana vitrectomy, membrane peel, partial air fluid exchange, sub-tenon's kenalog 20 mg for left eye, epiretinal membrane, and cystoid macular edema in the left eye.When the nurse was setting up the machine, the vacuum error message came on the machine, and the machine would not accept the cassette.The nurse checked the vacuum at the wall and it was working correctly.The nurse tried to setup the machine several times more without success.The machine was swapped out with another machine, and the procedure was completed without further incident.Patient to recovery room in satisfactory condition.

• Brand Name: STELLARIS VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH & LOMB; 180 east via verde; san dimas CA 91773
• MDR Report Key: 3899938
• MDR Text Key: 4428038
• Report Number: 3899938
• Device Sequence Number: 1
• Product Code: HQC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR