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

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Log files of the eva system were received by d.O.R.C.Review of the log files did not reveal a reason behind the reported event.Further investigation is needed.

Event Description

During a procedure, a surgeon noticed that the pressure inside the eye felt higher than the value presented on the screen (when in irrigation and not during air fluid exchange).The surgery was completed with the same unit.Patient harm did not occur.

Manufacturer Narrative

With regard to this complaint, no item was returned for investigation.Therefore, no investigation can be performed and no investigation results could be obtained.In addition, no additional information was received to determine the root cause of the reported event.Review of the device history record did not reveal any similar events or repeat issue(s).Hence, based upon the available information the cause of the reported event remains unknown.- attachment: [mir 2020-002413 final report signed 1222074-2020-00040 follow up 1.Pdf].

Event Description

During a procedure, a surgeon noticed that a pressure inside an eye felt higher than it should be.In the same time, a value of an irrigation pressure indicated on a screen of an eva unit was as expected (from the settings).The surgery was completed with the same unit.Patient harm did not occur.

• Brand Name: EVA, COMBINED MACHINE NCBF INCLUDING LASER (DORC 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: 10080094
• MDR Text Key: 197351418
• Report Number: 1222074-2020-00040
• 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

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Patient Sequence Number: 1