MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NGENUITY DIGITAL VISUALIZATION SYSTEM; MICROSCOPE, OPERATING & ACC AC-POWERED, OPHTHALMIC

Catalog Number 8065830001

Device Problem Insufficient Information (3190)

Patient Problem Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

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).

Event Description

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.

Manufacturer Narrative

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).

• Brand Name: NGENUITY DIGITAL VISUALIZATION SYSTEM
• Type of Device: MICROSCOPE, OPERATING & ACC AC-POWERED, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6614264
• MDR Text Key: 76740209
• Report Number: 2028159-2017-02377
• Device Sequence Number: 1
• Product Code: EPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065830001
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other