| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | TECNIS CL Foldable Silicone Intraocular Lens |
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| Generic Name | intraocular lens |
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| Regulation Number | 886.3600 |
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| Applicant | Johnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618 |
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| PMA Number | P880081 |
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| Supplement Number | S042 |
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| Date Received | 03/08/2019 |
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| Decision Date | 04/05/2019 |
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| Product Code |
HQL |
| Advisory Committee |
Ophthalmic |
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| Supplement Type | Special (Immediate Track) |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval to revise the TECNIS® CL, Model Z9002, Directions for Use (DFU) to inform the user of the interaction of silicone material with inherent risk factors (such as asteroid hyalosis) as follows:1) Addition of diabetic retinopathy as an example in Warning #10 to state: The use of silicone lenses in patients with current vitreoretinal disease or those who are at high risk for future vitreoretinal disease (i.e. diabetic retinopathy, etc.) that may require silicone oil as part of therapy should be reconsidered; and2) Addition of the following Warning #11: The use of Silicone intraocular lenses in patients with asteroid hyalosis has been associated with opacification of the implanted IOL. |
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