MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV 2.5 MM TRIPLE STEP FLARED PHACO NEEDLE. (DISPOSABLE)

Catalog Number	8400.22F01
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre b.V.).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6).Metal parts of hand piece flushed into anterior chamber of eye, may lead to foreign body reaction, a serious harm to patient, hence concluded as reportable.There is no information provided on any intervention, however, for an event like this, additional flushing or exploration may be required.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
We learned from a nurse who called in later in the afternoon that during a phaco procedure metal particles were flushed into the anterior chamber from a patient's eye.

• Brand Name: 2.5 MM TRIPLE STEP FLARED PHACO NEEDLE. (DISPOSABLE)
• Common Device Name: 2.5 MM TRIPLE STEP FLARED PHACO NEEDLE. (DISPOSABLE)
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7677696
• Report Number: 1222074-2018-00239
• Device Sequence Number: 13841412
• Product Code: HQE
• UDI-Device Identifier: 08717872020808
• UDI-Public: 08717872020808
• 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,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 05/01/2017

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: No Information
• Device Catalogue Number: 8400.22F01
• Device Lot Number: 2000383710
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2017
• Initial Report FDA Received Date: 07/11/2018
• 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