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

Model Number BL2363

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

A product specialist is scheduled to visit the site, and review the surgeon's settings.The device history record was reviewed, and no anomalies were found.The investigation is ongoing.

Event Description

The user facility in (b)(6) reported the machine settings were causing problems for the surgeon when trying to remove the last tiny fragment of cataract.A posterior capsule tear, and some dropped nucleus occurred.The surgeon converted to an anterior vitrectomy.

Manufacturer Narrative

The product specialist went to the site and revised the machine settings by reducing the bottle height, increased the vacuum, reduced the phaco pulses per second and this improved the machine performance.Based on all available information, the cause appears to be due to the operator's use of the device.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No further investigation or corrective action necessary.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 10763529
• MDR Text Key: 216582560
• Report Number: 0001920664-2020-00140
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K101325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL2363
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STELLARIS SYSTEM AND ACCESSORIES
• Patient Outcome(s): Required Intervention