MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-09 for PARAGON Z CRT manufactured by Pargaon Vision Sciences.
[123493694]
Patient is undergoing corneal reshaping therapy (crt) as prescribed by another doctor. He sleeps in rigid contact lenses to reshape the curvature of the cornea and help reduce myopia. The contact lenses are fitted flat under the pressure of the closed eyelid to effect the change. Risk with this therapy involve potential permanent scarring of the cornea and other corneal health changes, including keratoconus. Starting (b)(6) 2017, the patient exhibited early signs of corneal problems and the patient was warned that the crt carried a risk. One year later on (b)(6) 2017, he developed central corneal breakdown and his vision was reduced to 20/40 in the right eye due to severe central corneal haze and scarring. The crt lenses were immediately discontinued and the treatment initiated to preserve visual acuity. After one week, the condition had improved to allow for visual acuity to return to 20/20, but central scarring persist. Crt lenses have been permanently discontinued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080437 |
| MDR Report Key | 7951849 |
| Date Received | 2018-10-09 |
| Date of Report | 2018-10-05 |
| Date of Event | 2018-09-06 |
| Date Added to Maude | 2018-10-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PARAGON Z CRT |
| Generic Name | LENS CONTACT RIGID GAS PERMEABLE EXTENDED WEAR |
| Product Code | MWL |
| Date Received | 2018-10-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | PARGAON VISION SCIENCES |
| Manufacturer Address | GILBERT AZ 85233 US 85233 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-09 |