PMA P880081S042

Device: TECNIS CL Foldable Silicone Intraocular Lens
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P880081
Supplement: S042
Product code: HQL
Decision date: 2019-04-05
Classification: Intraocular Lens
Generic name: intraocular lens
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.

Current openFDA PMA Record#

Device: TECNIS CL Foldable Silicone Intraocular Lens
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P880081
Supplement: S042
Product code: HQL
Generic name: intraocular lens
Decision date: 2019-04-05
Decision code: APPR
Date received: 2019-03-08
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.