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

Model Number	8000.COM02
Medical Device Problem Codes	Intermittent Infusion (2341); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The eva is at the hospital.The suspected pump module has been replaced in the field, and has been returned back to dorc for investigation.No patient harm was caused.Investigation has been started.A supplemental will be filed with any new information.
Event or Problem Description
During the surgery, the eva gave irregular irrigation pressure, with no backflush.Hypotonic eye occurred.It was reported no patient harm had occurred.
Event or Problem Description
During the surgery, the eva gave irregular irrigation pressure, with no backflush.Hypotonic eye occurred.
Additional Manufacturer Narrative
The pump was returned to d.O.R.C.For investigation, however the problem could not be reproduced.Pump performance has been checked and all measured parameters were within specification.Nevertheless, the suspected pump was replaced preventively.Functioning of the suspected pump was tested by performing a fat (factory acceptance test).This fat performed by the d.O.R.C.After sales department is an exact copy of the test used by the pump manufacturer to check new pumps.The after sales fat test includes a hardware test (tests on motors, pressure sensors, pneumatic valves, vacuum pumps and system) and a functional test (general test, tests on flow and vacuum mode).To be able to determine the root cause of the problem, additional information has been requested from the hospital three times.However, no further information has been received to date.Therefore the root cause for this issue cannot be determined.
Additional Manufacturer Narrative
Investigation has been started.Follow up 11-09-2018: the investigation is still ongoing.This report is being submitted retrospectively.It was originally supposed to be submitted sep 2018.
Event or Problem Description
During the surgery, the eva gave irregular irrigation pressure, with no backflush.Hypotonic eye occurred.

• Brand Name: EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)
• Common Device Name: 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: 7586343
• Report Number: 1222074-2018-00173
• Device Sequence Number: 1555105
• Product Code: HQC
• UDI-Device Identifier: 08717872019659
• UDI-Public: 08717872019659
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2021

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
• Operator of Device: Physician
• Device Model Number: 8000.COM02
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/16/2018; 05/16/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 04/22/2021; 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1