MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA; PHACOEMULSIFICATION/VITRECTOMY SYSTEM

Catalog Number 8000.COM03

Device Problem Output below Specifications (3004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.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.

Event Description

We have been informed that during procedure, the laser was not strong enough.The surgeon was using the laser at 200mw and was getting the burn he wanted.He went all the way up to 800mw to achieve the burn he wanted.After that case, he switched to another machine and did not use that machine anymore that day.He switched out the interface and the unit was within specifications again.Due to the reported event surgery was prolonged > 30 minutes.No harm to the patient occurred.

Manufacturer Narrative

With regard to this complaint, a laser module was returned.Functional inspection of the laser module confirmed the low power output.The low power output was caused by a mechanical movement in the interface.This resulted in the position of the lens no longer properly aligned.Please note that this is a known phenomenon and that a corrective action has been implemented.

Event Description

We have been informed that during procedure, the laser was not strong enough.The surgeon was using the laser at 200mw and was getting the burn he wanted.He went all the way up to 800mw to achieve the burn he wanted.After that case, he switched to another machine and did not use that machine anymore that day.He switched out the interface and the unit was within specifications again.Due to the reported event surgery was prolonged > 30 minutes.No harm to the patient occurred.

Manufacturer Narrative

With regard to this complaint, a laser module was returned.Functional inspection of the laser module confirmed the low power output.The low power output was caused by a mechanical movement in the interface.This resulted in the position of the lens no longer properly aligned.Please note that this is a known phenomenon and that a corrective action has been implemented.Trend analysis indicates that the product is performing within anticipated rates.Complaints will be closely monitored to identify any significant adverse trends.The design of the interface has been improved to prevent misalignment of the lens.

Event Description

We have been informed that during procedure, the laser was not strong enough.The surgeon was using the laser at 200mw and was getting the burn he wanted.He went all the way up to 800mw to achieve the burn he wanted.After that case, he switched to another machine and did not use that machine anymore that day.I switched out the interface and the unit was within specifications again.Due to the reported event surgery was prolonged > 30 minutes.No harm to the patient occurred.

• Brand Name: EVA
• Type of Device: PHACOEMULSIFICATION/VITRECTOMY SYSTEM
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuiland, 3214V N; NL 3214VN
• Manufacturer (Section G): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuiland, 3214V N; NL 3214VN
• Manufacturer Contact: petra holland ; scheijdelveweg 2; zuiland, 3214V-N ; NL 3214VN
• MDR Report Key: 15860600
• MDR Text Key: 305346723
• Report Number: 1222074-2022-00085
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2023

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.COM03
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/17/2023; 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1