MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-29 for PARAGON CRT100 CONTACT LENS manufactured by Paragon Vision Sciences, Inc..
[143535068]
The event was reported by the eye care practitioner to paragon. The complaint was investigated by reviewing the device history record which indicated the lens met the release requirements. The lens was not returned for inspection. As indicated, the doctor suggested there was foreign body that may have been trapped under the lens which could have been the caused of the central ulcer. The patient's eye is completely healed and is back to wearing paragon crt100 lens.
Patient Sequence No: 1, Text Type: N, H10
[143535069]
The patient developed a small central ulcer on her right eye after wearing the lens (b)(6) 2019. The doctor reported there were some linear track marks that may indicate a foreign body was trapped under the lens. The patient also reported there was pain. The ulcer was treated with drops and lens wear was discontinued. When the patient returned on (b)(6) 2019, the ulcer was mostly healed, no loss of vision was reported or recorded. On (b)(6) 2019, the doctor noted the patient's eye has completely healed, there were no epithelial defects and no loss of vision. The patient has resumed lens wear and is doing well in the lenses.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020433-2019-00011 |
| MDR Report Key | 8562988 |
| Date Received | 2019-04-29 |
| Date of Report | 2019-04-29 |
| Date of Event | 2018-03-29 |
| Date Mfgr Received | 2019-03-29 |
| Device Manufacturer Date | 2019-03-14 |
| Date Added to Maude | 2019-04-29 |
| 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 |
| Manufacturer Street | 947 E. IMPALA AVE. |
| Manufacturer City | MESA AZ 852046619 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 852046619 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PARAGON CRT100 CONTACT LENS |
| Generic Name | PARAGON CRT |
| Product Code | MWL |
| Date Received | 2019-04-29 |
| Model Number | CRT100 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-04-29 |