MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-17 for SMILE manufactured by Carl Zeiss Meditec Ag.
[120728417]
I had smile surgery for both eyes on (b)(6) 2018 by dr (b)(6) at (b)(6) ctr in (b)(6). He told me i had no risks at all and will see well right after surgery. Now i have irregular astigmatism. I see glare, halos and starbursts from light sources during the day and night. I cannot drive in dark roads at night anymore. I have severe dryness in my eyes. Upon consulting a third party i came to know that he had treated an optical zone smaller than my scotopic pupil size. He hadn't even measured my pupil sizes. After surgery, he laughed at me when i told him my symptoms and denied his mistake. He said i have interface fluid that is causing my visual disturbances and i have higher order aberrations (hoas). He offered me lasik to fix it but i refused. When i left a review about the case on facebook, the cancelled my scheduled appts with him and he now refuses to see me. The owner of the clinic also blocked me on whatsapp. P. S: the surgeon himself wears glasses.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079848 |
| MDR Report Key | 7885076 |
| Date Received | 2018-09-17 |
| Date of Report | 2018-09-15 |
| Date of Event | 2018-02-15 |
| Date Added to Maude | 2018-09-18 |
| 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 | 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 | SMILE |
| Generic Name | FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION |
| Product Code | OTL |
| Date Received | 2018-09-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2018-09-17 |