MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-31 for PARAGON CRT100 CONTACT LENS manufactured by Paragon Vision Sciences, Inc.
| Report Number | 2020433-2019-00013 |
| MDR Report Key | 8847924 |
| Date Received | 2019-07-31 |
| Date of Report | 2019-07-29 |
| Date Mfgr Received | 2019-07-01 |
| Device Manufacturer Date | 2018-06-17 |
| Date Added to Maude | 2019-07-31 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PARAGON CRT100 CONTACT LENS |
| Generic Name | ORTHO-K LENS |
| Product Code | NUU |
| Date Received | 2019-07-31 |
| Returned To Mfg | 2019-07-01 |
| Model Number | CRT100 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARAGON VISION SCIENCES, INC |
| Manufacturer Address | 947 E. IMPALA AVE. AZ 852046619 US 852046619 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-31 |