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

Model Number BL2213

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Burn(s) (1757); Retinal Tear (2050)

Event Date 02/16/2018

Event Type  Injury  

Manufacturer Narrative

The unit was inspected by our b+l equipment specialist.The error code datalog on the stellaris was downloaded and reviewed.No error codes and no equipment failure were detected.The stellaris system was performing according to specification.The consumables used during the case were disposed by the user.

Event Description

A report received from a user facility in the (b)(6) stated that the surgeon had an issue with the irrigation function during a routine phaco+iol, vitrectomy & erm peel surgery.The surgery went well until almost at the end when performing an indented peripheral retinal search before closure.During the search, the eye suddenly went very soft and collapsed.The infusion setting was still on and the infusion bottle was checked which demonstrated there was still a quarter of a bottle of fluid left.The surgeon manually removed the infusion line and established that the infusion was not coming out of the line.We have not been able to collect any information regarding the patient's conditions due to patient confidentiality conditions.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): ST. LOUIS; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 7369596
• MDR Text Key: 103425957
• Report Number: 0001920664-2018-00038
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K101325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2018

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: Physician
• Device Model Number: BL2213
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other