MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-26 for OK 3 CONTACT LENS manufactured by Contex, Inc..
[19544247]
Rptr is an ophthalmologist who attended a seminar. At the seminar he was informed that lenses are ide devices not intended for general sale and use. Dr promptly requested a refund from the co and discontinued sales of the product. Rptr indicated that he would assist in an investigation of shipping practices of the co. He stated that the firm has been marketing these devices since 1982 for orthokeratology usage. He also stated in the same conversation on 4/12/93 that the firm is advertising these lenses in "all the journals. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000079 |
| MDR Report Key | 11115 |
| Date Received | 1994-01-26 |
| Date of Report | 1993-03-26 |
| Date Added to Maude | 1994-01-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OK 3 CONTACT LENS |
| Product Code | HQM |
| Date Received | 1994-01-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11115 |
| Manufacturer | CONTEX, INC. |
| Manufacturer Address | SHERMAN OAKS CA 91403 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-01-26 |