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Approved use: The Light Adjustable Lens and Light Delivery Device (LDD) system is approved for patients who have a cataract and need surgery for it, have corneal astigmatism (at least 0.75 diopters) before surgery, and do not have preexisting macular disease. Who should not receive this treatment?
https://www.fda.gov/news-events/press-announcements/fda-approves-first-implanted-lens-can-be-adjusted-after-cataract-surgery-improve-vision-without
FDA approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract ...
https://redlightman.com/delivery/
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https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160055B.pdf
The Light Delivery Device is a UV light projection system used to induce a predictable change in LAL power after implantation. The LDD consists of an anterior segment biomicroscope with the addition of an optical projection system, electronic control circuitry, and a UV source. The LDD device can treat postoperative manifest cylinder from -0.75 ...
https://www.healio.com/ophthalmology/cataract-surgery/news/online/%7B830c94eb-dc8c-4f40-8382-609a7090d485%7D/fda-approves-light-adjustable-lens-from-rxsight
Nov 22, 2017 · The FDA has approved the Light Adjustable Lens and Light Delivery Device from RxSight, according to an FDA press release. This is the first medical device system that can make adjustments to the ...
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https://www.empr.com/home/news/fda-approves-intraocular-lens-that-can-be-adjusted-post-cataract-surgery/
Nov 27, 2017 · The material of RxSight intraocular lens (IOL) reacts to UV light, which is delivered by the Light Delivery Device (LDD) about 17 to 21 days post-surgery.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2178026
Subject device malfunction is not the suspected root cause of the events reported. A lumenis healthcare professional evaluated the reported event details and patient photographs concluding double pass over the treatment area in contradiction to subject device training and device labeling to be the root cause of the events reported.
http://europepmc.org/patents/PAT/US2009204111
A light delivery device comprising an optical fiber having a non-feature portion and a feature portion having features that force light to couple out radially from the feature portion and provide a desired radial light output pattern.
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