MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for PARAGON CRT CONTACT LENS CRT100 manufactured by Paragon Vision Sciences, Inc..
[144796194]
The lenses were not returned for inspection. A follow up with the doctor's office indicated the patient is fine and is now wearing soft contact lenses. Since the patient did not want the lenses to be replaced, paragon issued credit for the lenses. A review of the device's dhr found the lens met our release requirements at the time of manufacture. No further action is required since microbial keratitis is a well-known riks when wearing any overnight contact lens. This risk is documented in paragon's labeling.
Patient Sequence No: 1, Text Type: N, H10
[144796195]
Patient started using paragon crt lenses in (b)(6) 2018. Initially the patient used improper care and handling techniques including solution storage. In (b)(6), the doctor reported the patient had improved the care of the lenses. No ulcer was noted during the (b)(6) doctor's visit. In (b)(6) 2019, the patient complained of pain and the doctor observed a corneal ulcer which required medical intervention with eye drops/antibiotics. The doctor discontinued the patient's wear of paragon crt and the ulcer resulted in a corneal scar. To date, the patient's ocular health is stable, and vision is good and unaffected by the scar. The patient is wearing soft contact lenses.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020433-2019-00012 |
| MDR Report Key | 8602155 |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-06 |
| Date of Event | 2019-01-18 |
| Date Mfgr Received | 2019-04-11 |
| Device Manufacturer Date | 2018-08-09 |
| Date Added to Maude | 2019-05-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. VIMALA PUNSAMMY |
| Manufacturer Street | 947 E. IMPALA AVE |
| Manufacturer City | MESA AZ 852046619 |
| Manufacturer Country | US |
| Manufacturer Postal | 852046619 |
| Manufacturer Phone | 4805077600 |
| Manufacturer G1 | PARAGON VISION SCIENCES, INC. |
| Manufacturer Street | 947 E. IMPALA AVE |
| Manufacturer City | MESA AZ 852046619 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 852046619 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PARAGON CRT CONTACT LENS |
| Generic Name | ORTHO-K LENS |
| Product Code | MWL |
| Date Received | 2019-05-10 |
| Catalog Number | CRT100 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARAGON VISION SCIENCES, INC. |
| Manufacturer Address | 947 E. IMPALA AVE MESA AZ 852046619 US 852046619 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-10 |