MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-11 for ORTHOKERATOLOGY CONTACT LENSES manufactured by .
[130025342]
This adverse event report is a follow up to the report submitted by (b)(6). The report submitted by (b)(6) suggested paragon z crt may have been involved in a patient related adverse event. According to the adverse event report submitted by (b)(6), the patient suffered central corneal breakdown and his vision was reduced to 20/40 in the right eye due to severe central corneal haze and scarring after wearing the lenses for one year.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020433-2018-00010 |
| MDR Report Key | 8153212 |
| Date Received | 2018-12-11 |
| Date of Report | 2018-11-30 |
| Date of Event | 2018-09-06 |
| Report Date | 2018-10-09 |
| Date Reported to FDA | 2018-10-09 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-12-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 85204 |
| Manufacturer Country | US |
| Manufacturer Postal | 85204 |
| Manufacturer Phone | 4805077600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ORTHOKERATOLOGY CONTACT LENSES |
| Generic Name | ORTHO-K LENS |
| Product Code | MWL |
| Date Received | 2018-12-11 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-11 |