MAUDE Adverse Event Report: D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV 2.2 MM TRIPLE STEP FLARED PHACO NEEDLE. (DISPOSABLE)

Catalog Number	8400.22F01
Medical Device Problem Code	Physical Property Issue (3008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/07/2014
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)(4)).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6) 2017.This incident occurred during surgery.Since the foreign particles felt in to eye, and it may leads to tissue damage to the eye, this complaint is concluded as reportable.Investigation could not reveal the root cause, due to not receiving the faulty article.Therefore this complaint is closed.All information has been disclosed.
Event or Problem Description
A report has been received of an event that occurred in (b)(6)."we received a complaint concerning phaco tips " two small metallic ""paillette"" fell from the tip in to the eye.No consequence for the patient, the surgeon aspirated it.There is no further information.No sample was returned.

• Brand Name: 2.2 MM TRIPLE STEP FLARED PHACO NEEDLE. (DISPOSABLE)
• Common Device Name: FLARED PHACO NEEDLE. (DISPOSABLE)
• Manufacturer (Section D): D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 7278529
• Report Number: 1222074-2018-00029
• Device Sequence Number: 11337875
• Product Code: HQC
• UDI-Device Identifier: 08717872018751
• UDI-Public: 08717872018751
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2014

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: 8400.22F01
• Device Lot Number: 2000360507
• 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: 10/07/2014
• Initial Report FDA Received Date: 02/16/2018
• 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