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	07/14/2015
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 (b)(4)).Details of this activity were discussed with (b)(4) office of compliance (b)(4) during a tele-conference on 05/31/2017.Electron microscopic investigation was done by a external company to determine the root cause.The investigation revealed no results that lead to indication how the issue could occur.Since it was reported small metal pieces coming from needle during surgery, metal pieces leads to reaction in the eye, hence there is harm to the patient.It is concluded as reportable.All available information has been disclosed.The complaint has now been closed.Please note: this incident is being reported as a serious injury since the particles or shavings were seen which reasonably suggests that the particles were retrieved.Metal particles shedding into the eye are likely to result in medical intervention therefore this complaint is being reported as a serious injury.
Event or Problem Description
Sales rep reported that during my visit the dr has to use a fragmentation needle to remove a hard lens.To our surprise we saw small pieces of metal in the sclerotomy that came from the needle.Sample is available.All information has been disclosed.

• 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: 7504638
• Report Number: 1222074-2018-00114
• Device Sequence Number: 16173587
• Product Code: HQC
• UDI-Device Identifier: 08717872016818
• UDI-Public: 08717872016818
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 07/14/2015

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?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2015
• Initial Report FDA Received Date: 05/10/2018
• 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