{"id":3357,"date":"2026-04-21T18:19:51","date_gmt":"2026-04-21T18:19:51","guid":{"rendered":"https:\/\/veraqueconsulting.com\/cr\/?p=3357"},"modified":"2026-04-21T18:19:51","modified_gmt":"2026-04-21T18:19:51","slug":"intraocular-lenses-iols-classification-and-grouping-in-costa-rica","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/cr\/intraocular-lenses-iols-classification-and-grouping-in-costa-rica\/","title":{"rendered":"Intraocular Lenses (IOLs): Classification and Grouping in Costa Rica"},"content":{"rendered":"<p><span data-contrast=\"auto\">Intraocular lenses (IOLs) are\u00a0implantable\u00a0ophthalmic medical devices intended to replace the eye\u2019s natural crystalline lens during cataract surgery or elective refractive procedures. Attributes such as optical design, material composition, and implantation technique influence not only device performance but also the applicable regulatory pathway in Costa Rica.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">This article outlines the main categories of intraocular lenses, their regulatory classification under the <a href=\"https:\/\/veraqueconsulting.com\/cr\/guides\/ultimate-guide-for-regulatory-affairs-in-costa-rica\/\">Costa Rican medical device framework<\/a> administered by the Ministry of Health, and the grouping principles considered when preparing a sanitary registration submission for market authorization.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">What Are the Main Categories of Intraocular Lenses?\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:0,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:278}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"auto\">IOLs vary in optical design, material composition, and delivery mechanisms. These characteristics directly affect regulatory expectations.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"15\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Monofocal\u00a0IOLs\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">The most common implant type, designed with a single fixed focal point. These lenses are typically straightforward in construction and are\u00a0submitted\u00a0with supporting optical and biocompatibility data.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"16\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Multifocal and Trifocal IOLs\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Advanced optical designs using diffractive or refractive zones to provide multiple focal points. These devices usually require\u00a0additional\u00a0performance data related to contrast sensitivity, halo\/glare analysis, and design rationale.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"17\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Toric IOLs\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Intended for patients with corneal astigmatism. Their classification and review emphasize rotational stability,\u00a0axis\u00a0alignment\u00a0indicators, and efficacy metrics for residual astigmatism.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"18\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Extended Depth of Focus (EDOF) IOLs\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Engineered to extend the range of\u00a0clear vision\u00a0without multiple discrete focal points.\u00a0Submissions generally include bench and clinical evidence demonstrating optical performance across distances.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li><span data-contrast=\"auto\">Phakic IOLs (Implantable Collamer or Lens-Based Refractive Implants)<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">These lenses differ from standard cataract implants because they are placed in phakic eyes. They typically undergo more stringent review due to the potential for endothelial cell loss and angler elated risks.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"20\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Preloaded and Injector-Integrated IOL Systems\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Some IOLs are supplied in a sterile,\u00a0single\u00a0use\u00a0injector system. These configurations may be grouped together with the implant when they are part of a unified commercial presentation.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">How Are IOLs Classified in\u00a0Costa Rica?<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:0,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:278}\">\u00a0<\/span><\/h3>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">In Costa Rica, medical device classification is overseen by the Ministry of Health. Under Decree No. 43902<\/span>\u2011<span data-contrast=\"auto\">S, invasive medical devices intended to remain in the body or to\u00a0maintain\u00a0contact with the surface of the eye for 30 consecutive days or more are classified as <strong>Class\u202f3<\/strong>.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Within this regulatory framework, standard intraocular lenses used in cataract surgery are regulated as <strong>Class\u202f3<\/strong> medical devices, as they are permanently implanted and intended for long<\/span>\u2011<span data-contrast=\"auto\">term contact with intraocular tissues.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Grouping Criteria for IOL Sanitary Registrations<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">The Costa Rican regulatory framework allows manufacturers to include multiple intraocular lens models under a single sanitary registration when defined consistency conditions are met. Appropriate grouping can support more efficient dossier preparation while\u00a0remaining\u00a0compliant with local requirements.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:0,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:278}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335559685&quot;:0,&quot;335559737&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:278}\">\u00a0<\/span><\/p>\n<ol>\n<li><b><span data-contrast=\"auto\">Same Manufacturer<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">All variants must originate from the same legal manufacturer or facility listed in the quality\u00a0system\u00a0documentation.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol start=\"2\">\n<li><b><span data-contrast=\"auto\"> Same Commercial Name<\/span><\/b><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">Grouping is\u00a0permitted\u00a0when the IOLs belong to a consistent product line or family with a unified brand or commercial designation.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol start=\"3\">\n<li><b><span data-contrast=\"auto\"> Same Intended Use<\/span><\/b><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">The lenses must share the same therapeutic purpose (e.g., visual rehabilitation following cataract extraction). Variants designed for different indications,\u00a0such as phakic use,\u00a0may require separate registrations.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ol start=\"4\">\n<li><b><span data-contrast=\"auto\"> Same Technology Platform<\/span><\/b><\/li>\n<\/ol>\n<p><span data-contrast=\"auto\">This refers to consistency in:<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Base\u00a0optical\u00a0design\u00a0(monofocal, multifocal, EDOF,\u00a0toric)<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Material type (hydrophobic acrylic, hydrophilic acrylic, silicone)<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Haptic configuration (C<\/span>\u2011<span data-contrast=\"auto\">loop, plate haptic)<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Delivery platform when part of a preloaded system<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Significant changes in optical mechanism (e.g.,\u00a0monofocal\u00a0vs. multifocal) or material formulation typically prevent grouping under a single registration.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Frequently Asked Questions (FAQ)<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<ol>\n<li data-leveltext=\"%1.\" data-font=\"\" data-listid=\"21\" data-list-defn-props=\"{&quot;335552541&quot;:0,&quot;335559683&quot;:0,&quot;335559684&quot;:-1,&quot;335559685&quot;:1080,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0,46],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">What is an intraocular lens (IOL)?<\/span><\/b><br \/>\n<span data-contrast=\"auto\">An intraocular lens is an artificial ophthalmic implant placed inside the eye, most commonly during cataract surgery, to restore focusing ability.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"%1.\" data-font=\"\" data-listid=\"21\" data-list-defn-props=\"{&quot;335552541&quot;:0,&quot;335559683&quot;:0,&quot;335559684&quot;:-1,&quot;335559685&quot;:1080,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0,46],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Why are IOLs classified as Class 3 in Costa Rica?<\/span><\/b><br \/>\n<span data-contrast=\"auto\">Because they are invasive devices that\u00a0remain\u00a0in contact with the surface of the eye or inside the body for more than\u00a030 days, they meet the criteria for Class 3 under Costa Rican Rule 2.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"%1.\" data-font=\"\" data-listid=\"21\" data-list-defn-props=\"{&quot;335552541&quot;:0,&quot;335559683&quot;:0,&quot;335559684&quot;:-1,&quot;335559685&quot;:1080,&quot;335559991&quot;:360,&quot;469769242&quot;:[65533,0,46],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;%1.&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Can several IOL models be included under one sanitary registration?<\/span><\/b><br \/>\n<span data-contrast=\"auto\">Yes, when the models belong to the same product family and share materials, optical technology, and intended use.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li>\n<\/ol>\n<p><span data-ccp-props=\"{&quot;335559685&quot;:720}\">\u00a0<\/span><\/p>\n<p><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"auto\">Conclusion<\/span><\/b><span data-ccp-props=\"{}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">In Costa Rica, intraocular lenses are regulated as\u00a0<\/span><b><span data-contrast=\"auto\">Class 3<\/span><\/b><span data-contrast=\"auto\">\u00a0medical devices due to their invasive nature and long<\/span>\u2011<span data-contrast=\"auto\">term interaction with ocular tissues. Familiarity with Costa Rican classification rules and grouping criteria supports more efficient regulatory planning, enables cohesive product family submissions, and helps ensure that technical documentation aligns with\u00a0the Ministry of Health requirements.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Medical device manufacturers and distributors\u00a0benefit\u00a0from addressing these requirements early when preparing IOL registration strategies for the Costa Rican market.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><a href=\"mailto:contact@veraqueconsulting.com\"><b><span data-contrast=\"none\">Partner with\u202fVeraque<\/span><\/b><\/a><b><span data-contrast=\"auto\">\u202f<\/span><\/b><span data-contrast=\"auto\">\u00a0for focused, practical guidance through Costa Rica\u2019s medical device regulatory framework.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Intraocular lenses (IOLs) are\u00a0implantable\u00a0ophthalmic medical devices intended to replace the eye\u2019s natural crystalline lens during cataract surgery or elective refractive procedures. Attributes such as optical design, material composition, and implantation technique influence not only device performance but also the applicable regulatory pathway in Costa Rica.\u00a0 &nbsp; This article outlines the main categories of intraocular lenses, [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":3358,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[367,386],"tags":[],"class_list":["post-3357","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-classification","category-costa-rica"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Intraocular Lenses: Classification and Grouping in Costa Rica - Veraque Costa Rica<\/title>\n<meta name=\"description\" content=\"Learn how intraocular lenses are classified in Costa 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