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

Model Number BL2364

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Capsular Bag Tear (2639); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The device was evaluated at the user facility.A complete check of the system did not find any anomalies.All values are within specification.The reported event was not duplicated and the system log does not show the event.A review of the device history record was completed and the device met specifications.Based on all available information, no causal factors can be determined and no conclusion can be drawn.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 required.If additional information from the user facility is received, the investigation will be reopened.No further investigation is necessary at this time.

Event Description

The user facility in (b)(6) reported a change in sequence without human intervention.A capsule rupture was reported.Multiple requests to the user facility for additional information regarding the event and patient impact have not been returned.

Manufacturer Narrative

Corrected section e4 the user facility did not report the event to the fda and corrected patient code from 3190 to 2639.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 10712402
• MDR Text Key: 212350847
• Report Number: 0001920664-2020-00129
• 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: 09/23/2020

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: Health Professional
• Device Model Number: BL2364
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STELLARIS SYSTEM AND ACCESSORIES