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

Model Number	8000.COM02
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Several reminders for providing extra information about this complaint and returning the defective articles have been sent, unfortunately we have not received extra information and the faulty articles.For this reason the complaint is closed.Considering the failure, a broken tip of the phaco needle may fall into the eye & may cause tissue reaction, hence it's reportable.(b)(4).No information reasonable suggests anyone was harmed.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
Their phaco fragmentation tip broke during surgery.Most likely lot numbers (b)(6) 2015 no sample and no report of injury.

• Brand Name: EVA, COMBINED MACHINE INCLUDING LASER (SMA CONNECTOR)
• Common Device Name: EVA, COMBINED MACHINE INCLUDING LASER (SMA CONNECTOR)
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7535346
• Report Number: 1222074-2018-00146
• Device Sequence Number: 13830932
• Product Code: HQC
• UDI-Device Identifier: 08717872019659
• UDI-Public: 08717872019659
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 01/21/2016

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: 8000.COM02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2016
• Initial Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1