MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2008-08-12 for FARGO "GP EXPRESS" manufactured by Gp Specialists.
[891611]
Father claims (b)(6) child wore fargo orthokeratology lens for 7 years. Upon terminating lens wear began to notice double vision in one or both eyes several weeks later which has persisted.
Patient Sequence No: 1, Text Type: D, B5
[8105317]
Paragon's first contact with the complainant was (b)(4) 2008, however, there has been earlier contact with the fitting od and the finishing lab ((b)(4) specialists). None have been able to elicit any information regarding the father's claim that the son has double vision or that it developed in the weeks following discontinuation of use of the lenses. Nor has the original fitting doctor been able to examine the son. The father has repeatedly promised to send medical reports or name the examining doctors but to date none have been received. Initial fitting (yr 2000) of the product was off label but paragon received approval in 2002 for its own product and the fargo design and the son's lenses were replaced in 2004. The visual deficiency was first noted at some time in late 2007 according to the father. Paragon is actively seeking further information, we will update this report as soon as any is obtained. At this time, more than half million eyes have been treated for 1-6 years by paragon's product and many more with other similar products without any prior report of persistent corneal distortion in the...
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020433-2008-00001 |
| MDR Report Key | 1121363 |
| Report Source | 00 |
| Date Received | 2008-08-12 |
| Date of Report | 2008-08-11 |
| Date Mfgr Received | 2008-07-31 |
| Date Added to Maude | 2011-07-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 947 EAST IMPALA AVE. |
| Manufacturer City | MESA AZ 85204 |
| Manufacturer Country | US |
| Manufacturer Postal | 85204 |
| Manufacturer Phone | 4805077606 |
| Manufacturer G1 | C&E, GP SPECIALISTS |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FARGO "GP EXPRESS" |
| Generic Name | ORTHOKERATOLOGY CONTACT LENS |
| Product Code | HPX |
| Date Received | 2008-08-12 |
| Model Number | NA |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GP SPECIALISTS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2008-08-12 |