MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. NUVISC; AID, SURGICAL, VISCOELASTIC

Lot Number	B160005A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial notification of event was (b)(6) 2016.Case was closed, but new information was received in (b)(6) causing the case to be reopened and an mdr generated.The new information was received on (b)(6) 2017.It was also stated by the reporter that the patient issue was resolved in a reasonable amount of time.This report was originally filed on (b)(6) 2017 on the test server.The account was approved and moved to the production server on (b)(6) 2017.I was informed to resubmit all previous files to the production server.Production account approval help desk ticket #(b)(4) notification of moving files to production account help desk ticket #(b)(4).Please find the original submission ((b)(6) 2017) from the test account attached.
Event or Problem Description
Initial report came in on (b)(6) 2016 as a voicemail: the voicemail stated; "we recently had a complaint about this product causing inflammation.I am calling to see how best to go about investigating this complaint." original case was closed, but new information was received on the (b)(6) 2017 informing us of a reportable event.New information: patient developed endophthalmitis.The condition was treated with an injection of unknown medication.Patient issue was reported to have resolved in a reasonable amount of time.

• Brand Name: NUVISC
• Common Device Name: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 6786470
• Report Number: 3007093114-2017-00004
• Device Sequence Number: 16294637
• Product Code: LZP
• UDI-Device Identifier: 30886158020067
• UDI-Public: 30886158020067
• Combination Product (Y/N): N
• PMA/510(K) Number: P000046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/15/2017

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?: No
• Operator of Device: No Information
• Device Expiration Date: 04/30/2018
• Device Lot Number: B160005A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2016
• Initial Report FDA Received Date: 08/10/2017
• 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: Required Intervention