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

Lot Number	D140074A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the amvisc tip shot out during a procedure and hit the patient in the eye.The facility indicated that they would be filing a medwatch report.No additional details were provided.Additional event information was received on 03/31/2017.The facility stated that the tip shot out as a result of the syringe burst while attempting to apply viscoelastic.The tip hit the patient in the left eye zonule area and the surgeon canceled the surgery, given that he no longer believed the zonules could safely hold the iol.The patient was advised to come back the following day and was told that they'd also be getting referred to a retinal specialist for the injury.

• Brand Name: AMVISC PLUS
• Common Device Name: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 6789701
• Report Number: 3007093114-2017-00011
• Device Sequence Number: 10803916
• Product Code: LZP
• UDI-Device Identifier: 07391899830605
• UDI-Public: 07391899830605
• 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): 08/11/2017

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: 08/31/2017
• Device Lot Number: D140074A
• 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: 04/03/2017
• Initial Report FDA Received Date: 08/11/2017
• 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