MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-10-05 for OK LENS ("NOT CONTACS") * manufactured by Max Lund O.d..
[135459]
Orthokeratology lens advertised by max lund od, 250 w. Valley blvd #k, san gabriel, ca 91776 as safe (proven) and can prevent progession of myopia for kids, to be worn at night. Pt suffered central cornea ulcer rt eye requiring cornea transplant. Now vision 20/70 corrected right eye, vision 20/20 corrected left eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017320 |
| MDR Report Key | 244780 |
| Date Received | 1999-10-05 |
| Date of Report | 1999-10-04 |
| Date of Event | 1997-07-10 |
| Date Added to Maude | 1999-10-18 |
| 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 LENS ("NOT CONTACS") |
| Generic Name | OK LENS |
| Product Code | MUW |
| Date Received | 1999-10-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 237145 |
| Manufacturer | MAX LUND O.D. |
| Manufacturer Address | 250 W. VALLEY BLVD. #K SAN GABRIEL CA 91776 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-10-05 |