MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV DISPOSABLE ECKARDT TWINLIGHT CHANDELIER. (27 GAUGE / 0.4MM)

Catalog Number	3269.MBD27
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation could not reveal the root cause, due to severe contamination.Since it is containing silicon dirt, foreign particles, can cause foreign body reaction to patient, hence it is concluded as reportable.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 cdrh office of compliance (b)(4) ) during a tele-conference on (b)(4) 2017.All available information has been provided.This complaint has now been closed.
Event or Problem Description
A report has been received of an event that occurred in (b)(6): there have been two particles which are probably from the silicon medical grade.It`s difficult to recognize at the photos but we could definitely see them.She tried to save them but they have been too thin so we lost them.

• Brand Name: DISPOSABLE ECKARDT TWINLIGHT CHANDELIER. (27 GAUGE / 0.4MM)
• Common Device Name: DISPOSABLE ECKARDT TWINLIGHT CHANDELIER. (27 GAUGE / 0.4MM)
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7480345
• Report Number: 1222074-2018-00092
• Device Sequence Number: 11204712
• Product Code: MPA
• UDI-Device Identifier: 08717872021942
• UDI-Public: 08717872021942
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K062895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2015

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 Catalogue Number: 3269.MBD27
• Device Lot Number: 2000368813
• 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: 04/28/2018
• Initial Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1