MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-09 for RELEX SMILE manufactured by Carl Zeiss.
[108049144]
I had smile surgery for my eyes. The surgeon's name is dr (b)(6). He did the treatment area (optical zone) smaller than my pupil size. My vision is terrible at night and i cannot drive anymore. He lied to me about everything and told me i was risk free. He did not admit his mistake but offered lasik to enhance his mistake. He says i have interface fluid and that's why i have glare during the day as well from reflective surfaces. My vision is especially terrible at night.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077100 |
| MDR Report Key | 7502156 |
| Date Received | 2018-05-09 |
| Date of Report | 2018-05-07 |
| Date of Event | 2018-02-15 |
| Date Added to Maude | 2018-05-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | RELEX SMILE |
| Generic Name | LASER OPHTHALMIC |
| Product Code | OTL |
| Date Received | 2018-05-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS |
| Brand Name | RELEX SMILE |
| Generic Name | LASER OPHTHALMIC |
| Product Code | HQF |
| Date Received | 2018-05-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-09 |