MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-02 for OPD - SCAN III manufactured by Marco Ophthalmic Inc..
[122850547]
I requested lens crafters not take any pictures of my eye. They put me in front of a machine and had me look into it, i asked what they were doing, she said measuring eyes and a very intense flash went off. It really affected me immediately. I was very alarmed and uncomfortable. Immediately after flash i experienced eye headache between eyes, glares, extreme sensitivity to light, and anxiety. I complained to assistant and doctor on site, cashiers and eye assistants when trying to purchase glasses. No one took the time out to sit me down and ask me if i needed assistance or water. They all ignored me. They never informed me or prepared me for the extreme flash a blue led light. I believe they purposely did this because i refused cameras before exam started. Affected quality of life, eyes are affected with glasses, eye sensitivity, and eye headaches affects driving and concentration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080311 |
| MDR Report Key | 7929989 |
| Date Received | 2018-10-02 |
| Date of Report | 2018-08-28 |
| Date of Event | 2018-06-08 |
| Date Added to Maude | 2018-10-03 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OPD - SCAN III |
| Generic Name | RETRACTOMETER, OPHTHALMIC |
| Product Code | HOX |
| Date Received | 2018-10-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MARCO OPHTHALMIC INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-02 |