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

Catalog Number 3005.F106

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/29/2016

Event Type  Injury  

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 Description

During the operation the phaco fragmentation needles broke in the eye.

• Brand Name: PHACO FRAGMENTATION NEEDLES, 23G / 0.6 MM, INCL. NEEDLE WRENCH
• Type of Device: 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
• Manufacturer (Section G): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• Manufacturer Contact: laura smith ; 10 continental dr; bldg 1; exeter, NH 03833 ; 6037786929
• MDR Report Key: 7598213
• MDR Text Key: 111000272
• Report Number: 1222074-2018-00188
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 08717872016818
• UDI-Public: 08717872016818
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 3005.F106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other