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

Catalog Number	8400.25A01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/28/2016
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) 201 the investigation was done on the returned needle.The needle only had a few scratches because the hand piece and the material that came off during surgery where not returned we where not able to determine the point of cause.Surgeon is expecting a medical intervention after his diagnosis on a week because of the broken particle.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
During surgery, the surgeon realized that there was a loose tip of metal on the tip of a phaco which had not broken yet.This was while the phaco was inside the patient`s eye and doctor had to take phaco out of patient`s eye.As a result of this event, there was a tear in the posterior capsule.According to the surgeon, it appears as though a part from the inside of the cutter is what broke off, internally from the tip.The surgeon wil be seeing the patient in a few weeks, only then will he know how the patient was affected.
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 05/31/201.The investigation was done on the returned needle.The needle only had a few scratches because the hand piece and the material that came off during surgery where not returned we where not able to determine the point of cause.Surgeon is expecting a medical intervention after his diagnosis on a week because of the broken particle.All available information has been disclosed.This complaint has now been closed.

• Brand Name: 2.5 MM TRIPLE STEP ANGLED FLARED PHACO NEEDLE. (DISPOSABLE)
• Common Device Name: 2.5 MM TRIPLE STEP ANGLED FLARED PHACO NEEDLE. (DISPOSABLE)
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7638183
• Report Number: 1222074-2018-00205
• Device Sequence Number: 2244715
• Product Code: HQC
• UDI-Device Identifier: 08717872018775
• UDI-Public: 08717872018775
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup
• Report Date (Section B): 10/28/2016

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: 8400.25A01
• Device Lot Number: 2000379996
• 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: 11/02/2016
• Supplement Date Received by Manufacturer: 11/02/2016
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 06/26/2018
• 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