MAUDE Adverse Event Report: SOLTA MEDICAL CLEAR + BRILLIANT LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAR

Model Number CB-CONSOLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 08/17/2018

Event Type  Injury  

Manufacturer Narrative

The clear+brilliant treatment tips do not delivery any energy and no treatment data is stored on the tip itself; there is no information to gather from their return.The exception to this would be if the clear+brilliant tip plastic housing or component scratched the patient.For other reported events, tips are not a viable source of evaluation data.System has no system/data logs that can be reviewed.System has software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits.Customer can also utilize the burn paper to confirm system laser is providing correct pattern/coverage.Customer performed burn paper test and sent it to product support for review.Review of burn paper showed proper pattern/coverage.The investigation is ongoing.

Event Description

A patient received a clear_brilliant permea treatment to the entire face on (b)(6) 2018 on a medium energy level.The patient claims a hyaluronic acid filler injected underneath the eyes has lessened the c+b permea treatment.The filler was injected twelve days prior to the (b)(6) treatment by a different clinic not affiliated with this doctor.On (b)(6) 2018 using a high energy level the patient elected to have a follow up c+b permea treatment and dr.(b)(6) injected additional hyaluronic acid filler.The patient has not responded to multiple follow-up attempts by the doctor.

Manufacturer Narrative

A patient reported their hyaluronic acid filler injections had lessened post clear+brilliant treatment.The filler was done by a different clinic, not affiliated with the clear + brilliant doctor.The patient had fillers completed 12 days prior to clear+brilliant treatment.Not all individuals will necessarily react the same way to the laser treatment.Appropriate judgment should be exercised at all times.According to clear+brilliant user manual (p009341-03 rev.A), clear+brilliant should not be used on patients if botox injections or dermal fillers (such as collagen) have occurred within 2 weeks prior to treatment.The customer reported no system errors or anything out of the ordinary occurred during treatment.Based on the available information, this patient was treated in an off label manner that is listed a contraindication for clear+brilliant.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record for this serial number.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 is necessary at this time.The investigation is complete.

• Brand Name: CLEAR + BRILLIANT LASER SYSTEM
• Type of Device: POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAR
• Manufacturer (Section D): SOLTA MEDICAL; 11720 n. creek prkw n; suite 100; bothell WA 98011
• MDR Report Key: 8032350
• MDR Text Key: 125921050
• Report Number: 3011423170-2018-00108
• Device Sequence Number: 1
• Product Code: ONG
• Combination Product (y/n): Y
• PMA/PMN Number: K120433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CB-CONSOLE
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other