MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for LASIK LASER DEVICE manufactured by Unk.
[184477278]
I had radial keratotomy in both eyes in the mid 1980s and went very far sighted in right eye. I had lasik in mid 1990s by a separate surgeon to correct far sightedness in the right eye. Both surgeons seemed pleased with their respective work's outcomes. I have had halos, starbursts, ghost images and daily visual fluctuations ever since and all, especially the daily visual fluctuations and ghost images are getting progressively and steadily worse. Neither glasses nor soft contacts give me usable vision. I now am dependent on scleral lenses. While my surgeries were years ago and the laser procedure was new, it is no longer new but these well-documented side effects seem to still be downplayed by the laser surgeons and industry as they continue to recruit new pts. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093829 |
| MDR Report Key | 9848258 |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-15 |
| Date Added to Maude | 2020-03-18 |
| 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 | 3 |
| Brand Name | LASIK LASER DEVICE |
| Generic Name | EXCIMER LASER SYSTEM |
| Product Code | LZS |
| Date Received | 2020-03-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | LASIK LASER DEVICE |
| Generic Name | EXCIMER LASER SYSTEM |
| Product Code | LZS |
| Date Received | 2020-03-17 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2020-03-17 |