MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-12 for PUNTELETS * manufactured by Unk.
[16702100]
I was diagnosed with dry eyes in 2003, one of the optometrist at facility put the puntlet in my tear ducts to help relieve dry eyes. My dry eyes continued to be bothersome and he placed another puntlet on top of the other approx a yr later. I questioned if that would be ok and he assured me that it was. In 2005, i started losing vision in my right eye and discovered i had a macular hole. My vision went from 20/20 with correct lens in the right eye to a shaky 20/40 with corrected lens. In 2008, i was diagnosed with another macular hole in my left eye and will need a second emergency surgery to repair the macular hole. My vision is now reduced in both eyes due to what i believe could somehow be caused by the puntlets. My belief is that the puntlets have caused the holes to form in my macular. I have no family history of this happening, and have not had any trauma injuries that would have caused this. Diagnosis or reason for use: dry eyes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5007618 |
| MDR Report Key | 1075445 |
| Date Received | 2008-07-12 |
| Date of Report | 2008-07-12 |
| Date of Event | 2008-07-10 |
| Date Added to Maude | 2008-07-18 |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PUNTELETS |
| Generic Name | PUNTLET |
| Product Code | HNW |
| Date Received | 2008-07-12 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1043752 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-07-12 |