MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. NUVISC; OPHTHALMIC VISCOELASTIC

Catalog Number 600108

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint is still under investigation.A supplemental report will be submitted upon receipt of new information or the investigation conclusion.

Event Description

On (b)(6) 2021, the distributor reported to anika that during a cataract surgery, the physician noticed two green floating particles in the nuvisc.The doctor did not notice the green particles prior to injecting the nuvisc into the patient's eye.The doctor reported that the particle was removed with phaco.The doctor believes the particles were removed.The device sample was requested for evaluation at the manufacturing plant.There was no report of any negative patient impact.Additional information was solicited.

Event Description

On 01dec2021, the distributor reported to anika that during a catarac surgery, the physician noticed two green floating particles in the nuvisc.The doctor did not notice the green particles prior to injecting the nuvisc into the patient's eye.The doctor reported that the particle was removed with phaco.The doctor beleives the particles were removed.The device sample was requested for evaluation at the manufacturing plant.There was no report of any negative patient impact.Additional information was solicited.

Manufacturer Narrative

The complaint is still under investigation.A supplemental report will be submitted upon receipt of new information or the investigation conclusion.Supplemental information: the reported event is not confirmed.The device was not available for return for evaluation at the manufacturing plant.Additional information was not provided upon request.A request for a photo of the device and particles was not provided.It was reported that there was no negative patient impact.A review of the batch record was performed.There was no nonconformances or deviations recorded in the manufacturing record.The reported event will be monitored and trended for future analysis.A supplemental report will be submitted upon receipt of new and relevant information.

• Brand Name: NUVISC
• Type of Device: OPHTHALMIC VISCOELASTIC
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins avenue; bedford MA 01730
• Manufacturer (Section G): ANIKA THERAPEUTICS, INC.; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: 32 wiggins avenue; bedford, MA 01730
• MDR Report Key: 13088093
• MDR Text Key: 285093261
• Report Number: 3007093114-2021-00316
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 600108
• Device Lot Number: 0000003728
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1