MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-06-24 for LIGHT SHEER LASER DIODE * manufactured by *.
[247426]
Immediately after receiving laser hair removal treatment of their eyebrow, the rptr's left eye was extremely irritated and sensitive to light. A segmental paralysis of left pupil was noticeable. Rptr was seen within hrs of the laser treatment by an opthalmologist. Inflammation and discomfort of eye occurred. Within 24-72 hrs after prednisone eye drops the shape of pupil changed from oblong shape to a more rounded shape but irritation, discomfort, spasms and light sensitivity remained. The left pupil appears to be stuck in one position and is very sluggish in its reaction to light. Blurred vision has developed in their left eye and the rptr experiences and continues to experience increased irritation and even pain in the left eye with reading and with a change in lighting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1025413 |
| MDR Report Key | 401999 |
| Date Received | 2002-06-24 |
| Date of Report | 2002-06-24 |
| Date of Event | 2002-05-28 |
| Date Added to Maude | 2002-07-01 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHT SHEER LASER DIODE |
| Generic Name | LASER USED FOR PERMANENT HAIR REMOVAL |
| Product Code | KCW |
| Date Received | 2002-06-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 391025 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-06-24 |