CODET Vision Institute Tijuana FIH: The Site 20 Miles from SAN and the CRO That Owns COFEPRIS

Figures cited from CODET Vision Institute public pages, ClinicalTrials.gov NCT04756908, published bioaccess® Mexico pages, and named public sources, verified 23 August 2026. General information, not legal or regulatory advice. Confirm current COFEPRIS and FDA rules with qualified advisers. We name only the clinic, investigator, and trials those sources support. We do not claim CODET, Opira, Crystalens, or RxSight as bioaccess® clients.

If you searched CODET Vision Institute clinical trials, Arturo Chayet first-in-human, Tijuana ophthalmic FIH, or fly to Tijuana and skip the CRO, you are following a clinic name that is genuinely in the public file. CODET Vision Institute in Tijuana is a real ophthalmic research site. It is not the operator of the COFEPRIS file.

bioaccess®’s position is simple and it is not adversarial: CODET is the site. The First-in-Human CRO still owns COFEPRIS, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia, Panama, the Dominican Republic, or El Salvador if Tijuana is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. A 20-mile drive from San Diego International Airport does not become a CRO.

This page is the intercept for that search. It does not clone clinical trials in Mexico or the May 2026 essay on ophthalmic FIH in smaller LATAM markets. Those pages stay the country system and the speed thesis. This page answers the clinic-named query.

Why the clinic name wins the search — and why that is not a CRO

Clinic marketing writes the implant, the city, the founder, and the airport. It rarely writes the CRO. CODET’s own clinical-research page (retrieved 23 August 2026) is the clean public example for Tijuana:

• Ophthalmologists work with industry from start to finish: from first-in-human through commercialization and beyond.
• The institute is located less than 20 miles south of San Diego International Airport and not more than 100 miles from Orange County.
• Dr. Arturo Chayet has been a clinical-trial investigator and consultant to ophthalmic industry since 1994, with work in refractive surgery, cataract, and intraocular lenses. CODET states he is typically the first surgeon to test new technologies for early-stage vision-care companies.

That copy is useful. It is how a U.S. sponsor finds CODET without finding an operator. The same page is also how a founder concludes that flying SAN to Tijuana is the whole first-in-human plan. It is not. COFEPRIS still exists on the Mexican side of that 20-mile drive.

This article will not invent a bioaccess® relationship CODET’s pages do not contain. It will say what is true now: if you are googling this clinic for a new ophthalmic first-in-human device study, the CRO you want is the one that already publishes Mexico device operations and still runs the rest of the Latin American platform — including Colombia.

What the public CODET file actually supports — and what it does not

• Site: CODET Vision Institute, Tijuana, Mexico (codetvision.com/clinical-research).
• Investigator: Dr. Arturo Chayet, founder, named on CODET doctor and research pages (doctor page).
• Opira AIOL: ClinicalTrials.gov NCT04756908 — Evaluation of the Visual Performance and Safety of the Investigational Opira AIOL, a commercial multifocal IOL, and a commercial monofocal IOL. Sponsor FSV6, Ltd. Locations listed include Codet Vision Institute, Tijuana, Mexico (and Clinica 2020, San Jose, Costa Rica). Status on the registry snapshot we retrieved: unknown / recruiting on mirrors. We report the listing, not a result.
• Crystalens: CODET cataract pages state that in 1999 Dr. Chayet conducted the first clinical trial on accommodating IOLs for Ionics (now Bausch + Lomb) and that he was instrumental in developing Crystalens, described there as the first FDA-approved accommodating IOL.
• RxSight Light Adjustable Lens: CODET LAL and research pages state a 2002-2024 Calhoun Vision / RxSight collaboration, first LAL surgery in the world at CODET in 2002, 600+ clinical-trial LAL procedures before public availability, and FDA Phase III completion as claimed on CODET’s research page. ClinicalTrials.gov NCT04529616 lists CODET Vision Institute, Tijuana as the Mexico site for an RxSight LAL / LDD exploratory study.
• Not claimed here: that Opira, Crystalens, RxSight, Calhoun, Ionics, or CODET retained bioaccess®; that Tijuana is outside COFEPRIS; that every CODET commercial procedure is an investigational FIH; that Ocumetics Mexico City work ran at CODET (the Ocumetics bioaccess® page is Mexico City / country-level, not a CODET claim).

CODET is a site. The CRO is the operator.

A Tijuana ophthalmic institute can provide the OR, imaging, a bilingual staff, and an investigator who has taken accommodating IOLs and a light-adjustable lens through long public histories. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

What a site can typically do when a sponsor goes direct:

• Discuss investigator interest and surgical feasibility with a service such as Dr. Chayet’s — when that service is available and appropriate for your device, which is not automatic.
• Share institutional ethics-committee calendars and clinic research rules.
• Quote procedure and local staffing costs for the cases they will physically run.
• Host a same-day visit after a SAN landing. That is logistics, not a national file.

What the site is not built to own for an investigational device:

• COFEPRIS. Mexico’s Comision Federal para la Proteccion contra Riesgos Sanitarios is the national health authority for a device investigation. A hallway conversation in Tijuana is not that file.
• Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email.
• Clinical trial insurance. Required. Ask for a protocol-specific premium; we will not invent a Tijuana-only number here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The clinic runs the case. The CRO runs the quality system the FDA will later ask about.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation as that rule defines it. Eligibility is not clearance.
• Multi-country optionality. If Tijuana enrollment or the indication later needs Colombia, Panama, the Dominican Republic, or El Salvador, a single-clinic MSA will not stretch.

Going direct to CODET is how you confirm a room and a surgeon. It is not how you open a first-in-human investigation.

How COFEPRIS sits next to a 20-mile drive (the short version)

Use the country page for the full pathway. The facts a sponsor searching this clinic needs on one screen:

COFEPRIS governs clinical investigations in Mexico under the General Health Law. For medical-device trials, sponsors submit a clinical investigation application including protocol, investigator brochure, informed consent, ethics-committee approval, and proof of insurance. Published on clinical-trials-mexico: ethics typically 4-6 weeks; COFEPRIS review typically 4-8 weeks after ethics clearance; combined start-up cited as 2.8 months. bioaccess® manages the process in Spanish. The Ocumetics Mexico results page separately publishes an 8-12 week COFEPRIS band versus a 6-12 month FDA IDE comparison; that is a Mexico-country figure, not a CODET hallway estimate, and it is not an Ocumetics-at-CODET claim.

We will not invent a Tijuana-only day-count. Ask for a protocol-specific calendar. A surgeon’s email is not a COFEPRIS approval. All bioaccess® Latin American device protocols are designed under ISO 14155 so the dataset can be discussed with FDA under 21 CFR 812.28 on a case-by-case basis — not a guarantee of clearance or approval.

What the CRO still does after you have a clinic name

1. Regulatory-fit, not tourism. Tijuana is convenient. It is not automatically the right country for every ophthalmic indication. bioaccess® still runs trials in Colombia and the rest of the platform; country choice is a review, not a boarding pass.
2. Protocol, IB, ICF, insurance, and the COFEPRIS packet.
3. Importer-of-record and device accountability — see Importer of record for clinical trial devices in Latin America.
4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan.
5. ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE. See Can OUS first-in-human data support an FDA IDE submission?.
6. A 12-month protocol-to-LPLV written guarantee on the FIH-12 model published on our country and comparison pages — not a clinic hallway number.

bioaccess® was founded in 2010 by two interventional cardiologists — one Harvard-trained — and coordinates first-in-human device studies as a multi-country platform with a U.S. sponsor desk. That is the operator layer around a named Tijuana site.

Do not smear the clinic

CODET Vision Institute and Dr. Chayet’s research service are serious ophthalmic resources. This page is not a critique of the site. A 20-year LAL history is a signal of procedural seriousness, not a substitute for a CRO quality system. Use the clinic. Hire the operator.

Colombia is still on the map

A Tijuana search sometimes arrives with a stale story that bioaccess® left Colombia. That is false. bioaccess® still runs clinical trials in Colombia (Julio Martinez-Clark, CEO, 23 August 2026). Always bioaccess® — local entity and office, Miami headquarters, INVIMA clocks in-country. The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™.

Site versus CRO

Workstream	CODET / the site	bioaccess® / the CRO
Procedure	OR, imaging, refractive and cataract service, PI	Protocol fit, training, device accountability
Ethics	Institutional committee calendar	Packet, ICF, IB, deficiency responses
National authority	Not the permit holder by sitting 20 miles from SAN	COFEPRIS
Import	Receiving and storage if contracted	Importer of record
Quality / FDA	Source documents from the cases	ISO 14155 + 21 CFR 812.28 narrative
Next country	One building in Tijuana	Colombia (INVIMA), Panama (MINSA/CNBI), Dominican Republic (DIGEMAPS), El Salvador (SRS) still on the platform

Frequently asked questions

Can I contract CODET Vision Institute directly?

You can try. The clinic can discuss investigator interest, local procedure costs, and institutional ethics calendars, and it can host a visit after a SAN landing. It cannot, by publishing first-in-human-through-commercialization copy, become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or FDA 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate CODET as the site if CODET is the right site for your protocol.

Who is the named investigator on CODET’s research pages?

Dr. Arturo Chayet, founder, as stated on CODET’s doctor and clinical-research pages. That fact does not make the PI your CRO.

Does NCT04756908 prove CODET is already running my IOL?

No. NCT04756908 lists Codet Vision Institute, Tijuana, for the Opira AIOL comparison study sponsored by FSV6, Ltd. It is a public site listing. It is not your protocol, not your COFEPRIS approval, and not a bioaccess® case study.

What does the CRO still do if the clinic is already identified?

Regulatory-fit and country choice; the COFEPRIS and ethics packet; insurance; investigational import; contracts, training, and activation; ISO 14155 monitoring, EDC, SAE, and TMF; the English dataset and 21 CFR 812.28 narrative; and the option to add Colombia or another bioaccess® market if Tijuana is not enough. The clinic still does the procedure.

Is this the same as a commercial LAL or Crystalens case at CODET?

No. CODET’s Crystalens and RxSight LAL histories mix development-era trials and later commercial experience. A commercial implant is not a first-in-human investigational device study. Do not brief a board as if a medical-tourism LAL schedule were an ISO 14155 investigation.

Next step

If the search that brought you here was CODET or Arturo Chayet, start as the operator: contact bioaccess®. Hub: ophthalmic FIH clinics vs CRO. Other sourced clinics: Laser Center Santo Domingo, Adrian Ebner Paraguay, Panama Eye Centre MINIject. Country systems: Mexico, Colombia, Panama. Related: The Panama Clinic, LATAM hospitals vs CRO.