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

Model Number 600-106

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Eye Injury (1845)

Event Date 06/16/2020

Event Type  Injury  

Event 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
• Type of Device: SODIUM HYALURONATE
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiggins ave; bedford, ma
• Manufacturer Contact: rebecca obeng ; 32 wiggins ave; bedford, ma ; 4579000
• MDR Report Key: 10321132
• MDR Text Key: 200402847
• Report Number: 3007093114-2020-00006
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 00866142000045
• UDI-Public: 00866142000045
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P00046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 600-106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR