MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV FEATHERLIGHT MICRO PHACO EMULSIFICATION/FRAGMENTATION HANDPIECE

Catalog Number	3002.P
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2017
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.V.).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6).Incident caused harm to the patient, hence it is reportable.No further information on the inventions performed due to the eye injury.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
Reported by sales, who collected the hand piece at the customer: today the leading nurse, complained about this ultrasonic handpiece.Very bad situation.After a few seconds the handpiece become extremely hot with completely missing phaco power.The surgeon reported this is a very bad situation, he had descemet folds, and the eyes look not really good.

• Brand Name: FEATHERLIGHT MICRO PHACO EMULSIFICATION/FRAGMENTATION HANDPIECE
• Common Device Name: FEATHERLIGHT MICRO PHACO EMULSIFICATION/FRAGMENTATION HANDPIECE
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7669825
• Report Number: 1222074-2018-00233
• Device Sequence Number: 16805124
• Product Code: HQC
• UDI-Device Identifier: 08717872008899
• UDI-Public: 08717872008899
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081877
• 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
• Report Date (Section B): 03/23/2017

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: No Information
• Device Catalogue Number: 3002.P
• Device Lot Number: 201600277
• 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: 03/23/2017
• Initial Report FDA Received Date: 07/09/2018
• 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