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

Model Number BL11114

Device Problem Increase in Suction (1604)

Patient Problem Vitrectomy (2643)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

Field service technician on site evaluated the stellaris unit after the case and performed service procedure according to manufactures standard.There was no malfunction of the unit.The device history was reviewed and found to meet manufacturing specification.Further investigation underway.

Event Description

The user facility in (b)(6) reported during the fourth cataract surgery of the day the doctor observed a rise in vacuum which lead to posterior capsule rupture.Additional information received states that no issues occurred for the first 3 cases.On the 4th case, the doctor continued the surgery and implanted an iol for the patient after he performed an anterior vitrectomy procedure.The patient was released from hospital after the procedure.

Manufacturer Narrative

The product evaluation results stated, after the case a service procedure was performed according to manufactures standard, and no malfunction was found.Therefore, the root cause of the reported complaint is unknown.The lot history, trend analysis, risk analysis and or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action is required.Investigation is complete.

• Brand Name: STELLARIS VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 8941751
• MDR Text Key: 159791501
• Report Number: 0001920664-2019-00177
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K063331
• 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: 01/01/2005,08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL11114
• Device Catalogue Number: BL11114
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention