MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR); PHACOEMULSIFICATION/VITRECTOMY SYSTEM

Catalog Number 8000.COM02

Device Problem Output Problem (3005)

Patient Problem Loss of Vision (2139)

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

The complaint is currently under investigation.No corrective or preventive actions can be implemented until the investigation has been completed.In case of a product return, the device will be investigated, otherwise we will review the device history record, and/or any log files if available, or try to replicate the problem on similar product.As investigations on the actual product or representative sample of a batch may alter the device, we request to inform us within 7 days after submission of this report, in case the investigations that alter the device should be halted until approval of the nca, as per article 89 of eu-mdr.

Event Description

We have been informed that during vitrectomy surgery, an error message occurred.The patient has lost vision in the operated eye.

Manufacturer Narrative

From the logfiles it can be concluded that the involved eva comes frequently with warning message "air41".This warning tells the user that the backup air pressure for the air-module is not working.The backup air pressure (also called safety air pressure) is there to allow the system to work in a "safe state'' for a while when the power to the system would be lost warning air41 can be ignored by the user, and the system will work as normal.However, in case of a total power loss, the backup air pressure will not work from the logfile investigation, there is no other malfunctioning of the device found.The reported vision loss in the patient's eye cannot be related to the "air41" warning message; the eva system.Therefore, the incident is assessed as not reportable.The reported vision loss in the patient's eye cannot be related to the "air41" warning message; the eva system.Therefore a review of the risk assessment is not applicable.

Event Description

We have been informed that during vitrectomy surgery, an error message occurred.The patient has lost vision in the operated eye.

• Brand Name: EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)
• Type of Device: PHACOEMULSIFICATION/VITRECTOMY SYSTEM
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer (Section G): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer Contact: petra holland ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 18002549
• MDR Text Key: 326468177
• Report Number: 1222074-2023-00076
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8000.COM02
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1