MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-06-06 for MAGELLAN MAPPER * manufactured by Nidek Technologies Srl.
[274482]
Performing repentibility & reproductibility testing on magellan corneal topographer. After 10 minutes eyes became irritated & dry. Cornea of eye was red, irritated and painful in bright light. Product is prototype and used a class ii laser target.
Patient Sequence No: 1, Text Type: D, B5
[275498]
Add'l info rec'd from mfr 6/27/03: in response to filing of the osha documents which assert that radiation from the magellan mapper corneal topographer may have caused a keratitis with secondary iritis in reporter's employee, co is offering the following as incontrovertible evidence that not only is there no scientific or clinical basis for this claim, but that it is in face impossible. To that end if it is possible to file an amended report it would be greatly appreciated. Co will first address the issue of the fda class of the product versus the class of the red laser that is used to align the instrument in z. The instrument is class 1 and requires no 510k. The laser, emitting red light at 635-670 nm, is a class 2 device, but is electronically controlled with double feedback loops that limit its output to that of a class 1 device. Failure of these loops will result in the laser not operating. In addition fda protocols for class 1 devices require that there be no optical components that could fail that would allow greater radiation to fall upon eye. There are no such components in the magellan mapper. Secondly, what would happen if the impossible occurred and the laser somehow was powered up to class 2 radiation? The fact is that the retina, not the cornea would be affected. There is no possibility that a diffuse keratitis would be the result of such an incident as the cornea is for practical purposes transparent to red light at the wavelength and maximum power emitted by the laser. The effect of red light is quasi thermal in nature. Since red light is not absorbed in the cornea, it has no thermal effect there. In addition, the laser used in the instrument is a smallspot on the cornea. So if any effect occurred it would not be diffused throughout the cornea. Note that the cornea is a good absorber of uv light, so one might question the diodes that are used for illuminating the cone. These diodes have a very small range of wavelengths in their emissions that are no where near the uv spectrum. So the only uv light present would be ambient in nature. The most probable reason for the pt's keratitis was dryness secondary to the 80 examinations that were performed in a 2 hour period, which was necessitated due to problems encountered in image acquistion because the magellan software was being run on windows xp and not windows 2000 as specified in earlier meetings and in e-mails in march and april. There is also the possibility of an underlying condition that was exasperated by the dryness. These are far more probable scenarios than any cause attributed to the magellan.
Patient Sequence No: 1, Text Type: D, B5
[327658]
Add'l info received from mfr 6/27/03: in response to filing of the osha documents which assert that radiation from the magellan mapper corneal topographer may have caused a keratitis with secondary iritis in reporter's employee, co is offering the following as incontrovertible evidence that not only is there no scientific or clinical basis for this claim, but that it is in fact impossible. To that end if it is possible to file an amended report it would be greatly appreciated. Co will first address the issue of the fda class of the product versus the class of the red laser that is used to align the instrument in z. The instrument is class 1 and requirs no 510k. The laser, emitting red light at 635-670 mm, is a class 2 device, but is electronically controlled with double feedback loupes that limit its output to that of a class 1 device. Failure of these loops will result in the laser not operating. In addition fda protocols for class 1 devices require that there be no optical components that could fail that would allow greater radiation to fall upon the eye. There are no such components in the magellan mapper. Secondly, what would happen if the impossible occurred and the laser somehow was powered up to class 2 radiation? The fact is that the retina, not the cornea would be effected. There is no possibility that a diffuse keratitis would be the result of such an incident as the cornea is for practical purposes transparent to red light at the wavelength and maximum power emitted by the laser. The effect of red light is quasi thermal in nature. Since red light is not absorbed in the cornea, it has no thermal effect there. In addition, the laser used in the instrument is a small spot on the cornea. So if any effect occurred it would not be diffused throughout the cornea. Note that the cornea is a good absorber of uv light, so one might question the diodes that are used for illuminating the cone. These diodes have a very small range of wavelengths in their emissions that are no where near the uv spectrum. So the only uv light present would be ambient in nature. The most probable reason for the employee's keratitis was dryness secondary to the 80 examinations that were performed in a 2 hour period, which was necessitated due to problems encountered in image acquisition because the magellan software was being run on windows xp and not windows 2000 as specified in earlier meetings and in emails in march and april. There is also the possibility of an underlying condition that was exasperated by the dryness. These are far more probable scenarios than any cause attributed to the magellan.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1041845-2003-00001 |
| MDR Report Key | 465613 |
| Date Received | 2003-06-06 |
| Date of Report | 2003-06-05 |
| Date of Event | 2003-05-27 |
| Date Facility Aware | 2003-05-30 |
| Report Date | 2003-06-05 |
| Date Reported to FDA | 2003-06-05 |
| Date Added to Maude | 2003-06-16 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAGELLAN MAPPER |
| Generic Name | CORNEAL TOPOGRAPHER |
| Product Code | HJB |
| Date Received | 2003-06-06 |
| Model Number | MAGELLAN MAPPER |
| Catalog Number | * |
| Lot Number | * |
| ID Number | MFR DATE 2003/01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 454556 |
| Manufacturer | NIDEK TECHNOLOGIES SRL |
| Manufacturer Address | VIA REGIN 88 VIGONZA, PADOVA * 35010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-06-06 |