MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC; SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION

Lot Number	0000011003
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation at the manufacturing plant.
Event or Problem Description
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by (b)(6) or its employees that the report constitutes an admission that the device, (b)(6), or its employees, caused or contributed to a potential patient event documented in this report.On 09dec2025 medsun mdr report 3500a (b)(4) was received by (b)(6).It was reported that the blue flange part of the syringe for 3 orthovisc injectables were missing when the packaging was opened.Pn 630254 lot number: 0000011003 expiration date: 15nov2026.Device not available for return.Complainant office became aware of the issue may 2025.Office did not obtain a picture of the syringe missing the flange.The office staff did not note any unusual appearances to the device (besides missing the blue flange).There was no defect with the device or packaging observed prior.There was no negative patient or user impact reported.

• Brand Name: ORTHOVISC
• Common Device Name: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins ave; bedford MA 01730
• Manufacturer (Section G): ANIKA THERAPEUTICS, INC; 32 wiggins ave; beford MA 01730
• Manufacturer Contact: lee perloff ; 32 wiggins ave; bedford, MA 01730
• MDR Report Key: 23910626
• Report Number: 3007093114-2025-00020
• Device Sequence Number: 18440347
• Product Code: MOZ
• UDI-Device Identifier: 00817337000111
• UDI-Public: 00817337000111
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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: Other
• Device Lot Number: 0000011003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown