MAUDE Adverse Event Report: D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV EVA VITRECTOMY PACK GRAVITY INPUT 23G

Catalog Number	8300.23G01
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Intraocular Pressure, Delayed, Uncontrolled (1936)
Date of Event	01/27/2015
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 centre (b)(4)).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6) 2017.This complaint occurred during surgery.Hence this incident has been concluded as reportable.The risk identified based upon the description is possible hypotony.There is no information that the involved patient was harmed.No sample was returned, therefore unable to confirm this complaint.Incident occurred during surgery, bad irrigation may lead to hypotony which is a serious harm to patient, hence concluded as reportable.
Event or Problem Description
A report has been received of an incident that occurred in (b)(6) the following was reported: "we received an official complaint concerning a problem with the infusion line.At the beginning of the 23g vitrectomy, eye without tone.Bad irrigation.The infusion line show a defect at the output.Eye without tone - (serious risk to the patient).

• Brand Name: EVA VITRECTOMY PACK GRAVITY INPUT 23G
• Common Device Name: EVA VITRECTOMY PACK GRAVITY INPUT 23G
• Manufacturer (Section D): D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands ; NL
• MDR Report Key: 7359528
• Report Number: 1222074-2018-00049
• Device Sequence Number: 11197676
• Product Code: HQE
• UDI-Device Identifier: 08717872018997
• UDI-Public: 08717872018997
• 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,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 01/27/2015

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: 8300.23G01
• Device Lot Number: 2000364454
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2015
• Initial Report FDA Received Date: 03/21/2018
• 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