MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-06-06 for NGENUITY DIGITAL VISUALIZATION SYSTEM 8065830001 manufactured by Alcon Research, Ltd. - Irvine Technology Center.
[76740209]
Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76740210]
A surgeon reported that a patient had worsening vision following one day postoperative retinal membrane peel. Upon follow up, the surgeon indicated it was too early to tell if the event is actually a complication from surgery. Additional information has been requested. This is one of two reports for this facility.
Patient Sequence No: 1, Text Type: D, B5
[79155202]
A company clinical analyst reviewed this case and stated the following:? The customer reported? Diminished vision.? Additional information received from the surgeon indicated it was too early to tell if the event is actually a complication from surgery. No further information has been received. Indocyanine green (icg) selectively stains the internal limiting membrane (ilm) of the retina, and helps to visualize and remove the membrane from the retina. Toxicity and damage to the retina has been reported in studies following macular surgery. Toxic effects can occur to retinal glial cells, to the nerve fiber layer, to retinal ganglion cells, and to the optic nerve. In case of subretinal application, the retinal pigment epithelium can be affected. The mechanisms of toxicity are unclear. Whether the dye itself or some preparations only are causing harm to the retina is subject of an ongoing debate. Icg changes the light absorption properties of the ilm and enhances the stiffness of the membrane, probably by crosslinking of collagen fibers. This effect is responsible for the ease of membrane removal compared to unaided ilm peeling with better visualization. Whether a phototoxic effect plays a clinically significant role in macular surgery has neither been proven nor ruled out yet. Icg at concentrations higher than 1. 25% or application of the dye in air are very likely causing retinal damage. In addition, lower concentrations also carry the risk of iatrogenic damage, depending on the final concentration of potentially toxic substances at the vitreomacular interface and on other mechanisms. Modifications in technique have primarily focused on efforts to reduce the potential toxicity of icg. These modifications have included variations in the icg concentration, limiting the staining time, and reduction of light intensity and exposure time. Protecting the hole with a viscoelastic substance to keep the bare retinal pigment epithelium from being exposed to the icg solution also has been reported. The exact mechanism for the potential toxicity is not known. Possible mechanisms include a direct toxic effect of icg to the retinal pigment epithelium (rpe) cells and/or retina. In vitro studies have shown that exposure of icg to cultured human rpe cells results in dose and time dependent damage to cellular structure. Also, it has been shown that icg exposure results in alterations in cellular function in human rpe cell cultures. Another potential mechanism is enhanced phototoxicity. Although the use of icg improves visualization of the ilm and should reduce surgical time and time of light exposure, icg may reduce the "safe time" for light exposure, and therefore increase the potential for light toxicity. ? No further information was able to be obtained from this customer. With no additional, related information provided, the customers reported event was not able to be confirmed. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028159-2017-02377 |
| MDR Report Key | 6614264 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-06 |
| Date of Report | 2017-06-29 |
| Date Mfgr Received | 2017-06-16 |
| Date Added to Maude | 2017-06-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NADIA BAILEY |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| Manufacturer G1 | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
| Manufacturer Street | 15800 ALTON PARKWAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NGENUITY DIGITAL VISUALIZATION SYSTEM |
| Generic Name | MICROSCOPE, OPERATING & ACC AC-POWERED, OPHTHALMIC |
| Product Code | EPT |
| Date Received | 2017-06-06 |
| Model Number | NA |
| Catalog Number | 8065830001 |
| Lot Number | NA |
| ID Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
| Manufacturer Address | 15800 ALTON PARKWAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-06 |