Effective October 1, 2020

iovera° Returned Goods Policy

GeneralIn the event that you would like to return to Pacira Pharmaceuticals, Inc. (“Pacira”) an iovera° product, this “Returned Goods Policy” sets forth the necessary requirements. All returns are subject to the iovera° General Terms and Conditions.

Return AuthorizationBefore returning any product, you must obtain a Returned Goods Authorization (“RGA”). An RGA can be obtained by contacting iovera° Customer Service at 1-800-442-0989 or ioveraReturns@icsconnect.com or by fax at 1-833-958-2048. You must follow all instructions provided with the RGA.

RGAs must be used within thirty (30) calendar days of issuance. All returns which do not have prior authorization will be denied credit or an exchange.

Eligibility for Credit or ExchangeWhether returns related to product defect are eligible for credit or exchange will be determined pursuant to the Warranty set forth in the iovera° General Terms and Conditions. For all other returns, Pacira reserves the right to determine, in its sole discretion, whether returned product is eligible for credit or exchange.

To seek an exchange or credit for reasons related to order processing or shipment error, an RGA must be requested within thirty (30) calendar days of the invoice date. Products also must be returned in original, saleable condition to be eligible for credit or exchange.

Credit valued at the invoiced purchase price will be issued for authorized returns upon confirmation of receipt of the product by Pacira. You should include a copy of the original packing slip or invoice with any returned product. Exchanges issued prior to return of product will be issued at no cost subject to confirmation of receipt of the product by Pacira within thirty (30) calendar days of issuance of the RGA. Pacira is not responsible for returns lost and/or damaged in transit.

Any product received by Pacira that does not meet all of the above conditions will be returned to sender at the sender’s expense.

IndicationThe iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera° system is not indicated for treatment of central nervous system tissue. The iovera° system’s “1x90” Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator.

Important Safety Information

ContraindicationsThe iovera° system is contraindicated for use in patients with the following:

  • Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud’s disease, and open and/or infected wounds at or near the treatment site

Potential ComplicationsAs with any surgical treatment that uses needle-based therapy and local anesthesia, there is a potential for site-specific reactions, including, but not limited to:

  • Ecchymosis, edema, erythema, local pain and/or tenderness, and localized dysesthesia

Proper use of the device as described in the User Guide can help reduce or prevent the following complications :

  • At the treatment site(s): injury to the skin related to application of cold or heat, hyper- or hypopigmentation, and skin dimpling
  • Outside the treatment site(s): loss of motor function
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The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain.

Important Safety Information