MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS POSTERIOR COMBINED SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number BL2364

Device Problems Display or Visual Feedback Problem (1184); Loss of Power (1475)

Patient Problem No Information (3190)

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

The device history was reviewed and found to meet manufacturing specifications.This investigation is ongoing.

Event Description

The user facility in (b)(6) reported during surgery, the stellaris display screen turned grainy and flashed.The surgery was aborted and not completed.Additional information has been requested.

Manufacturer Narrative

The product was not returned for evaluation.The lot history, trend analysis, risk analysis, and/or directions for use were reviewed and considered acceptable, with the product performing within anticipated rates.No corrective action is required.This investigation is complete.

Manufacturer Narrative

The product was not returned for evaluation, but was evaluated by the field service engineer on site.It was determined that the problem is the pcb of the pfm module, but this part cannot be replaced separately.Consequently, the module was changed.Therefore, the root cause was determined to be a component issue.This investigation is complete.

Manufacturer Narrative

Model#: bl2364, serial#: (b)(6).The stellaris unit was evaluated on site by the field service engineer.The issue with the touch screen could not be replicated.The computer module was replaced as a precautionary measure.The unit was tested and met all specifications.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.

• Brand Name: STELLARIS POSTERIOR COMBINED SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 9565689
• MDR Text Key: 177417409
• Report Number: 0001920664-2020-00003
• 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,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/01/2005,12/12/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: BL2364
• Device Catalogue Number: BL1433
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 01/13/2020; 02/24/2020; 03/09/2020
• Supplement Dates FDA Received: 02/07/2020; 03/02/2020; 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention