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

Model Number BL2273

Device Problems Energy Output Problem (1431); Power Conditioning Problem (1474)

Patient Problems Eye Injury (1845); Retinal Injury (2048)

Event Date 03/16/2018

Event Type  Injury  

Manufacturer Narrative

The laser module was removed from the stellaris system and is en route to bausch + lomb for investigation.

Event Description

We received notification from a user facility in the (b)(6) of an incident involving the laser module in the stellaris system.The report stated that on low power the system did not provide sufficient laser output, however upon increasing the power, a hole was burnt into the retina.Additional information regarding the patient outcome has been requested and will be be provided when received.

Manufacturer Narrative

The laser ultrasound module was received and evaluated.Functional testing found the module met all performance specifications.Damage to the fiber optic patch cable was initially reported but not confirmed during depot evaluation.Additional attempts were made to obtain further clarification of the circumstances of the event but no additional details could be provided.The disposable accessories used during the event were not available for evaluation.A review by the design engineering group found no reliability or performance issues that are related to the event description.As a result, we are unable to determine a root cause for the event.The lot history, trend analysis, risk analysis and/or direction for use review, were considered acceptable with the product performing within anticipated rates.We will continue to monitor complaints and take further action if required.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): ST. LOUIS; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 7421077
• MDR Text Key: 105142408
• Report Number: 0001920664-2018-00049
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K101325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL2273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2015
• 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