MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV PHACO FRAGMENTATION NEEDLES, 23G / 0.6 MM, INCL. NEEDLE WRENCH

Catalog Number	3005.F106
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fragmentation needle broke into eye during procedure, would lead to reaction or pieces or particles in the eye requiring removal or retrieval, hence 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)(6)) during a tele-conference on (b)(6) 201 this incident is being filed as a serious injury since pieces of an instrument in the eye may require manual retrieval which is medical intervention or further evaluation.An incident like this is reasonable to assume the patient required medical intervention.The lot is unknown and no sample was returned for an evaluation, therefore considered not confirmed.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
During the operation the phaco fragmentation needles broke in the eye.

• Brand Name: PHACO FRAGMENTATION NEEDLES, 23G / 0.6 MM, INCL. NEEDLE WRENCH
• Common Device Name: PHACO FRAGMENTATION NEEDLES, 23G / 0.6 MM, INCL. NEEDLE WRENCH
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7598213
• Report Number: 1222074-2018-00188
• Device Sequence Number: 19132952
• Product Code: HQC
• UDI-Device Identifier: 08717872016818
• UDI-Public: 08717872016818
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/29/2016

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: 3005.F106
• 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: 06/29/2016
• Initial Report FDA Received Date: 06/13/2018
• 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