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

Model Number	600-106
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Cannula dislodged during use in cataract surgery and hit patient's eye, requiring an anterior vitrectomy.Tech and surgeon state cannula was screwed on tightly.It was reported that patient was in stable condition.

• Brand Name: ANIKAVISC
• Common Device Name: SODIUM HYALURONATE
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiggins ave; bedford, ma
• MDR Report Key: 10321132
• Report Number: 3007093114-2020-00006
• Device Sequence Number: 935720
• Product Code: LZP
• UDI-Device Identifier: 00866142000045
• UDI-Public: 00866142000045
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P00046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 600-106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/24/2020
• 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
• Patient Age: 63 YR