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

Model Number BL15455

Device Problem Use of Device Problem (1670)

Patient Problem Phototoxicity (2165)

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

There is a photo toxicity message on the screen, and photo toxicity is explained in the device user manual.The incident was not reported by customer for 26 days after the incident.The stellaris system issued a warning message las07 - ensure that the eye safety filter is installed (endo mode) and operating room personnel have proper eye protection - during the timeframe of the incident.The root cause is inconclusive.The device history was reviewed and found to meet manufacturing specification.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.

Event Description

The user facility reported two cases of photo toxicity occurring while using the stellaris system with dorc tissue blue dye.The patient was noted at post-op visit to have significant pathology in the eye and vision loss.

• Brand Name: STELLARIS ELITE VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore
• MDR Report Key: 11577664
• MDR Text Key: 249123870
• Report Number: 0001920664-2021-00030
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2021

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: BL15455
• Device Catalogue Number: BL15455
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2018
• 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