MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-30 for LIPIFLOW THERMAL PULSATION SYSTEM LFH-1000 manufactured by Tearscience.
[2366835]
Patient had a pre-existing history of severe dry eye symptoms with severe keratopathy, lagophthalmos, corneal scarring, recurrent corneal erosion and meibomian gland dysfunction. The patient also had a prior history of eye pain in the left eye. Prior to treatment, the patient had an inferior band of punctate corneal staining and corneal scars noted. After treatment on the same day, the patient's cornea was unchanged on slit lamp evaluation. At a scheduled appointment two days after treatment, the cornea was the same as before (unchanged from prior to treatment). The patient returned four days after treatment and an increase in corneal punctate staining in the left eye was observed. The patient was seen at the emergency room complaining of pain in the left eye five days following treatment. A corneal abrasion was noted in the medical record and the patient was treated with a topical antibiotic and ointment. A week and a half later, the patient returned to the treatment physician; mild corneal staining was observed in the left eye but there was no corneal abrasion. The left eye had healed with no permanent sequelae.
Patient Sequence No: 1, Text Type: D, B5
[9679649]
No medical records were provided. The only information provided was through conversation with treating physician, who reported that the device did not cause the event (corneal abrasion) because the patient's eye was unaffected immediately after treatment and at two days after treatment. Therefore, the details of the patient's history, including event occurrence and severity, other factors that may have contributed to the event, and any other related information about the patient are unknown because the medical records were not available. This event is being reported as a corneal abrasion, worst case, which may or may not meet the definition of serious injury. Since the severity of the event is unknown and since the patient was reportedly treated with an antibiotic prophylactically to prevent infection, this event is being reported conservatively as a serious injury, even though there was no permanent impairment to the patient. In addition, it is extremely unlikely that the device caused a corneal abrasion because there was no abrasion or any adverse effect present immediately after treatment or within two days after treatment. The device was not available for evaluation. The device history record and retained samples were evaluated and met specs. However, since the event occurred within one week after treatment, this event is being reported conservatively because we cannot rule out the possibility that the device treatment contributed to the event. It is most likely that the corneal abrasion was a direct result of the patient's pre-existing condition, eye pain in the left eye, recurrent corneal erosion and severe keratopathy in both eyes, which makes the patient predisposed to chronic and repeated corneal staining and abrasion. In addition, an ocular surface abnormality that may compromise corneal integrity, such as recurrent corneal erosion, is a labeled contraindication of the device treatment in the instructions for use. Additional model number: lfd-1000.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008169506-2011-00001 |
| MDR Report Key | 2394901 |
| Report Source | 05 |
| Date Received | 2011-11-30 |
| Date of Report | 2011-11-30 |
| Date of Event | 2011-10-22 |
| Date Mfgr Received | 2011-11-01 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2012-01-04 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRISTY MOCNY |
| Manufacturer Street | 5151 MCCRIMMON PARKWAY SUITE 250 |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194594817 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPIFLOW THERMAL PULSATION SYSTEM |
| Product Code | ORZ |
| Date Received | 2011-11-30 |
| Model Number | LFH-1000 |
| Lot Number | 110725 |
| Device Expiration Date | 2013-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEARSCIENCE |
| Manufacturer Address | MORRISVILLE NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-11-30 |