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

Model Number 8000.COM03

Device Problem Unintended Movement (3026)

Patient Problem Halo (2227)

Event Type  malfunction  

Manufacturer Narrative

Additional information is requested at the user facility.Currently we can not rule out a potential user error where a lio with an incorrect safety filter has been used by the end-user.D.O.R.C.Requested the complaint article from the customer.An investigation will be initiated as soon as it is provided.

Event Description

We were informed that during use of eva in combination with a lio the surgeon was hit by unfiltered laser light and noticed to have green halos in the peripheral vision.After changing the lio, the surgeon was able to complete the case.Patient harm did not occur.

Event Description

We were informed that during use of eva in combination with a lio the surgeon was hit by unfiltered laser light and noticed to have green halos in the peripheral vision.After changing the lio, the surgeon was able to complete the case.Patient harm did not occur.

Manufacturer Narrative

With regard to this complaint, only pictures from the laser indirect ophthalmoscope (lio) used at the time of the event were received for investigation.Review of these pictures revealed that the wavelength of the laser filter of the lio used is 577 nm.Hence, the lio used during the event includes an incorrect safety filter (i.E.The wavelength of the eva machine is 532 nm and the wavelength of the lio used is 577 nm) which did not protect the user from the emitted 532 nm laser light.Review of supply records indicated that the lio used during the event was not supplied by dorc.In the instruction manual of eva safety procedure regarding the use of the laser module are included and instruct the user to ensure that when using laser everyone in the room must wear appropriate eye protection suited for 532 nm.In addition, eva prompts the user to confirm that a correct filter is in place prior to be able to activate the laser.Based upon the available information it is concluded that the reported event is attributed to the user not following the manufacturer's instructions.No generic remedial or corrective/preventive actions are proposed as a result of this incident, however, the site where the event occurred was reminded to only use laser filters with 532 nm.

• Brand Name: EVA, COMBINED MACHINE INCLUDING LASER (SMA CONNECTOR)
• Type of Device: PHACOEMULSIFICATION/VITRECTOMY SYSTEM
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA; scheijdelveqeg 2; zuiland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 9688368
• MDR Text Key: 195117697
• Report Number: 1222074-2020-00010
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup

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: No Information
• Device Model Number: 8000.COM03
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2020
• Patient Sequence Number: 1