MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-16 for OPHTHALMIC FEMTOSECOND LASER manufactured by Unk.
[97667115]
I had relex smile surgery with femtosecond laser on (b)(6) 2017 at (b)(6), (b)(6). On about (b)(6), i noticed several large black cobweb floaters floating in one eye. I was never told that this was a potential side effect. I am now suffering from partial vision loss and it is severely impacting my family and work life. I am only (b)(6) and i never saw these floaters pre-surgery. The surgeon told me that it was a "coincidence" that i got a post vitreous detachment since i was already myopic. In the pre consultation, the surgeon, dr (b)(6) never told me that i was already at risk of getting a pvd. I am deeply upset by this and wish i stayed with my contact lenses. I use a computer daily and am haunted by so many cobwebs floating in my vision in meeting rooms, outside etc. I have had several panic attacks and have had trouble sleeping and have lost weight. The surgery never did a pupil dilation test for my consultation. This procedure should be banned from all clinics until clinics advise pts the risk of getting a pvd or significant floaters after the surgery. I was never informed of this potential side effect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074631 |
| MDR Report Key | 7200333 |
| Date Received | 2018-01-16 |
| Date of Report | 2018-01-14 |
| Date of Event | 2018-01-15 |
| Date Added to Maude | 2018-01-17 |
| 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 | OPHTHALMIC FEMTOSECOND LASER |
| Generic Name | OPHTHALMIC FEMTOSECOND LASER |
| Product Code | OTL |
| Date Received | 2018-01-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | OPHTHALMIC FEMTOSECOND LASER |
| Generic Name | OPHTHALMIC FEMTOSECOND LASER |
| Product Code | OOE |
| Date Received | 2018-01-16 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-01-16 |