MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC ANIKAVISC; SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC

Lot Number	0000000559
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Eye Injury (1845); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used in this event was discarded and is not available to be returned for evaluation.This report is a report filed to correct evaluation codes for mdr3007093114-2018-00007.Original submission had a note stating "must have valid device problem code".
Event or Problem Description
It was reported that during surgery the cannula popped off the syringe and went through the iris of the patient.It is reported to not have caused permanent damage.

• Brand Name: ANIKAVISC
• Common Device Name: SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 7778759
• Report Number: 3007093114-2018-00008
• Device Sequence Number: 16473661
• Product Code: LZP
• UDI-Device Identifier: 00866142000045
• UDI-Public: 00866142000045
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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): 08/13/2018

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: Health Professional
• Device Expiration Date: 03/31/2020
• Device Lot Number: 0000000559
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/13/2018
• 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