MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-08-02 for LIPIFLOW THERMAL PULSATION SYSTEM LFD-1000 220100 manufactured by Tearscience, Inc..
[81589623]
Concomitant medical products: of the meibomian glands at the same treatment visit as the lipiflow. A superficial corneal abrasion may or may not result in permanent damage of the cornea if left untreated. However, a permanent injury in the absence of medical management cannot be ruled out. The lipiflow cannot also be ruled out as a possible contributing factor in the development of the abrasion. As such, we elected to report the event. The activator used for the treatment (lfd-1000) was discarded by the practice after the treatment. However, there was no indication that a pre-treatment inspection of the activator revealed any defects in the activator or packaging, the activator passed the automated self-test of the device and the device records indicate that the treatment operated according to the intended specifications. This case is complicated by several factors: the patient had a history suggestive of undiagnosed recurrent corneal erosion (sporadic episodes of pain and inflammation lasting for a few hours especially in the evening). Rce is a listed contraindication in the labeling. The patient received manual expression and lipiflow on the event day, both requiring the use of proparacaine which is known to irritate the corneal epithelium. Manual expression involves physical manipulation & pressure applied to eyelid. The treatment plan, to place a contact lens and additional proparacaine over a cornea with 'trace spk' is unusual and likely itself to result in disruption of the corneal epithelium. It is not known how much the patient used the proparacaine between leaving and returning to the office. The lipiflow system activator (disposable), which is a component of the lipiflow system, is the medical device suspected to have contributed to the patient injury. Ocular surface irritation or inflammation (e. G. Corneal abrasion, conjunctival edema or conjunctival injection (hyperemia)) and ocular symptoms (e. G. Burning, stinging, tearing, itching, discharge, redness, foreign body sensation, visual disturbance, sensitivity to light) are listed as potential adverse effects that can occur as a result of the procedure involving the lipiflow system. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[81589624]
The patient had a diagnosis of meibomian gland dysfunction, dry eye and moderate to severe chronic allergic conjunctivitis. The patient history was suspicious for undiagnosed recurrent corneal erosion. The patient was treated with the lipiflow followed by manual expression of the meibomian glands on the same day. After both treatments, the patient reported feeling 'watery and scratchy' in the left eye. The medical records shows that 'trace spk' was observed on the left eye. A bandage contact lens was placed on the left eye for the 'trace spk'. The patient was also given proparacaine drops to use as needed twice or three times a day along with lotemax (lotemax was prescribed to manage the patient's dry eye). The patient was instructed to return to the office in a few weeks for her routine follow up post-lipiflow and manual expression. A few hours later the patient returned to the office reporting pain. The bandage lens was then removed. Mild corneal edema was noted on the chart. The patient was prescribed topical steroid drops to use every 2 hours and she was referred to corneal specialist the next day. The corneal specialist diagnosed the patient with a superficial corneal abrasion and treated her prophylactically with an antibiotic drop, four times a day, for three days along with a topical steroid drop, twice a day, for 14 days. At the follow up exam after 3 days, the patient cornea was notably improved and it continued to heal over the next 2 weeks. Three weeks after the adverse event the cornea was documented as normal and the best corrected vision in the left eye was documented as 20/20. Comparison of the subjective refraction findings from 2 weeks prior to the lipiflow and manual expression and at both the optometrist and ophthalmologists offices after the treatment day indicate that the patient experienced a change in her prescription from her current older glasses. The prescription change in the left eye was larger than that in the right eye. The refractive data between the two offices were not fully consistent. There are no post-treatment keratometry data available. The patient has not received or required any additional medical intervention since (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008169506-2017-00001 |
| MDR Report Key | 6759764 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-08-02 |
| Date of Report | 2017-08-01 |
| Date of Event | 2017-06-01 |
| Date Mfgr Received | 2017-06-09 |
| Date Added to Maude | 2017-08-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STEPHEN BEVERSLUIS |
| Manufacturer Street | 5151 MCCRIMMON PARKWAY SUITE 250 |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194594831 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPIFLOW THERMAL PULSATION SYSTEM |
| Generic Name | EYELID THERMAL PULSATION SYSTEM |
| Product Code | ORZ |
| Date Received | 2017-08-02 |
| Model Number | LFD-1000 |
| Catalog Number | 220100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEARSCIENCE, INC. |
| Manufacturer Address | 5151 MCCRIMMON PKWY STE 250 MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-02 |