MAUDE Adverse Event Report: CANDELA CORPORATION GENTLELASE PRO U

Model Number 9914-00-9030

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949); Protective Measures Problem (3015)

Patient Problems Eye Injury (1845); Headache (1880); Inflammation (1932); Red Eye(s) (2038); Eye Pain (4467)

Event Date 07/12/2022

Event Type  Injury  

Manufacturer Narrative

A service history review for gl-pro u:9914-9030-6092 revealed no similar events.On site device review completed 2 months post event on 9/19/2022.Service history was reviewed and confirmed the device met candela specifications as of march 2022 post preventive maintenance visit.The gentlelase pro-u laser operator's manual warns: candela does not recommend treating the area within the orbital rim as ocular damage may occur.The gentlelase pro-u laser operator's manual cautions: the laser beam emitted by the gentlemax pro laser system is capable of causing loss of vision.The laser system operates at 755 nm and 1064 nm, which do not fall within the visible spectrum.The cornea and lens of the eye are transparent to invisible light.Any energy emitted by the gentlemax pro laser system that enters the eye will be focused directly on the retina.Direct contact of the laser beam on the retina can cause temporary clouded vision, retinal lesions, long-term scotian (vision absence in an isolated area), long term photo-phobia (sensitivity to light), or loss of vision.Position patient comfortably and confirm that the patient and everyone in the treatment room are wearing the correct protective eyewear.Since the therapist did not use safety glasses during treatment, the cause for this event is unintended use error caused or contributed to event indicating that the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device.Review of risk management documents demonstrate that the reported risk is captured and assessed.No further corrective actions required for this complaint at this time.Risk information is then subject to periodic risk reviews and trend tracking, which may require additional actions and/or review.

Event Description

A patient in australia reported an adverse event directly to a candela corporation representative.According to the patient, she is a 36-year-old female with fitzpatrick skin type 2 who reported she had treatment for "freckles" under her eyes with a gentlelase pro-u laser at laser clinic of australia (lca) located in victoria, australia "approximately 2 months" prior.The patient reported she saw a flashing in her eye during treatment and was advised it was normal.Patient noticed her pupil was "unequal and misshapen" when she got home.Patient reported "the therapist did not use safety glasses during treatment." furthermore, according to the patient, when she followed up with the clinic in september 2022 and reported she was diagnosed with uveitis, the treatment provider responded indicating the patient must have a "sensitive eye." the patient notes multiple appointments with both an optometrist and an ophthalmologist and has been diagnosed with traumatic uveitis to her left eye.She has been treated with "prednisone forte steroid eye drops and cyclopentolate to help with the inflammation and misshapen pupil." treatment is ongoing.Patient also reports taking regular panadol for the photosensitivity because the photosensitivity is causing headaches.Candela reached out to customer, lca for additional information.Per response from lca: to the best of our knowledge based on reports from lca northland and client communications provided in accordance with our laser clinics incident notification process.Lca northland pty ltd provided the services to the client (patient) on (b)(6) 2022.Patient only notified the lca northland clinic on (b)(6) 2022 by email of an incident involving laser treatment to her face.The incident relates to an alleged flash to her eye.Patient described to her own medical doctor intermittent flashing to the left eye post the event." reported treatment parameters: 18 mm spot size and fluence of 16 j/cm2.Lca reported having a telephone consultation with patient.As patient had sought treatment from her own medical doctors, no further post treatment care was provided by lca.

• Brand Name: GENTLELASE PRO U
• Type of Device: GENTLELASE PRO U
• Manufacturer (Section D): CANDELA CORPORATION; 251 locke drive; marlborough MA 01752
• Manufacturer (Section G): CANDELA CORPORATION; 251 locke drive; marlborough MA 01752
• Manufacturer Contact: greg wallender ; 251 locke drive; marlborough, MA 01752 ; 5083587400
• MDR Report Key: 15581303
• MDR Text Key: 301597425
• Report Number: 0001218402-2022-00003
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K140732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9914-00-9030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Female