MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)

Catalog Number	8000.COM02
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	Intraocular Pressure, Delayed, Uncontrolled (1936)
Date of Event	06/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed during the retrospective review.Investigation determined an unstable reducer and defective pcb.After replacing this parts and readjusting the air, the vfie module is working according specifications.The complaint is confirmed.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer ((b)(4).Details of this activity were discussed with (b)(6) during a tele-conference on (b)(6) 2017.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
A report from (b)(6) has been received and report a soft eye issue when switching from phaco to vitrectomy in 25 combined prog.At our customer there are infusion problems on eva.The surgeon still hears the sound of the drops/drop noise, but there is no infusion, why the eyes collapse.There is no information on intervention provided.

• Brand Name: EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)
• Common Device Name: EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7568989
• Report Number: 1222074-2018-00171
• Device Sequence Number: 11311225
• Product Code: HQC
• UDI-Device Identifier: 08717872019659
• UDI-Public: 08717872019659
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 8000.COM02
• Device Lot Number: 2013000104
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2016
• Initial Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other