MAUDE Adverse Event Report: D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV EVA, COMBINED MACHINE

Model Number	8000.COM01
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation showed that the printer was defect.We see this as an incident.Replacement has already been send.The cause was determined to be a software issue.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre (b)(4) ).Details of this activity were discussed with cdrh office of compliance ((b)(4)) during a tele-conference on 05/31/2017.The risk identified was cornea injury/trauma.Therefore determined to be reportable.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
A facility in (b)(6) has reported the following: "can you please make a complaint phaco suddenly stops working, error message not known." sample was returned.All information has been disclosed.No report of patient injury.

• Brand Name: EVA, COMBINED MACHINE
• Common Device Name: EVA, COMBINED MACHINE
• Manufacturer (Section D): D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 7283267
• Report Number: 1222074-2018-00034
• Device Sequence Number: 143646
• Product Code: HQC
• UDI-Device Identifier: 08717872019642
• UDI-Public: 08717872019642
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2014

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.COM01
• Device Catalogue Number: 8000.COM01
• 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: 11/17/2014
• Initial Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1