MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV FEATHERLIGHT MICRO PHACO EMULSIFICATION/FRAGMENTATION HANDPIECE

Catalog Number	3002.M
Medical Device Problem Codes	Material Separation (1562); Physical Property Issue (3008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reviewed during the retrospective review.The investigation showed that the parts of the wire are broken of the phaco needle.And metal parts where found inside the hand piece.The investigation could not reveal the root cause.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)(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
We received this phako handpiece from our customer who reported that during a surgery came little metal splinters in the eye.All information has been disclosed.The sample is available for evaluation.No further information as to the status of the patient.

• Brand Name: FEATHERLIGHT MICRO PHACO EMULSIFICATION/FRAGMENTATION HANDPIECE
• Common Device Name: FEATHERLIGHT MICRO PHACO EMULSIFICATION/FRAGMENTATION HANDPIECE
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7565525
• Report Number: 1222074-2018-00166
• Device Sequence Number: 1524369
• Product Code: HQC
• UDI-Device Identifier: 08717872008899
• UDI-Public: 08717872008899
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2016

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: 3002.M
• Device Lot Number: 01-31624
• 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: 05/03/2016
• Initial Report FDA Received Date: 06/04/2018
• 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; Required Intervention