RETISERT (Fluocinolone Acetonide) Implant [Bausch Lomb Incorporated]

Patients should be advised to have ophthalmologic follow-up examinations of both eyes at appropriate intervals following implantation of RETISERT.

As with any surgical procedure, there is risk involved. Potential complications accompanying intraocular surgery to place RETISERT into the vitreous cavity may include, but are not limited to, the following: cataract formation, choroidal detachment, temporary decreased visual acuity, endophthalmitis, hypotony, increased intraocular pressure, exacerbation of intraocular inflammation, retinal detachment, vitreous hemorrhage, vitreous loss, and wound dehiscence.

Following implantation of RETISERT, nearly all patients will experience an immediate and temporary decrease in visual acuity in the implanted eye which lasts for approximately one to four weeks post-operatively.

Based on clinical trials with RETISERT, within 3 years post-implantation, approximately 77% of patients will require IOP lowering medications to control intraocular pressure and 37% of patients will require filtering procedures to control intraocular pressure.[see Adverse Reactions (6.1)].

Based on clinical trials with RETISERT, during the 3-year post-implantation period, nearly all phakic eyes are expected to develop cataracts and require cataract surgery.

Manufactured for:
Bausch & Lomb Incorporated
Bridgewater, NJ 08807 USA

Manufactured by:
Bausch Health Ireland Limited
d/b/a Bausch & Lomb Ireland
Waterford, Ireland

Retisert is a trademark of Bausch & Lomb Incorporated or its affiliates.
© 2019 Bausch & Lomb Incorporated or its affiliates

9028009

Revised 05/2019

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