Raindrop Inlay Recall and Your Near Vision: How Liberty Laser Eye Center Provides the Safest, Proven Reading Vision Correction Without Implants

The U.S. Food and Drug Administration formally warned in 2018 that the Raindrop Near Vision Inlay posed a significant risk of corneal haze, vision loss, and endothelial cell damage, prompting the manufacturer to voluntarily recall the device worldwide. No iteration of this implant has returned to the U.S. market. We at Liberty Laser Eye Center never adopted the Raindrop inlay—our trusted, FDA-approved laser platforms have always delivered presbyopia correction without the irreversible risks of a corneal insert.

Why We Are Writing About a Recalled Implant in 2026
We continue to meet patients who received the Raindrop inlay at other practices and now experience progressive blur, halos, or dry eye. They come to us seeking clarity on whether the implant is truly unsafe and what corrective options exist. This article addresses those concerns head-on, confirms the FDA’s position, and shows why Liberty Laser Eye Center’s non-implant solutions—backed by over 30,000 successful procedures—remain the safest long-term strategy for reading vision.

What Exactly Was the Raindrop Near Vision Inlay?

The Raindrop was a tiny hydrogel disc, about the diameter of a pinhead, surgically placed in the cornea of one eye to reshape the surface and improve near vision. Marketed as an alternative to reading glasses, it was approved by the FDA in 2016 under the brand name Raindrop Near Vision Inlay (manufactured by ReVision Optics). The idea was compelling: a quick, outpatient procedure that created a multifocal corneal profile without removing tissue.

In reality, the inlay altered corneal physiology in ways that triggered unpredictable cellular responses. Within two years, post-market data painted a very different picture.

The FDA Safety Alert: A Timeline of the Raindrop Inlay’s Failure

To understand why the implant is unsafe, a brief regulatory history helps. We have distilled the key milestones from the FDA’s own safety communication and medical device database.

• June 2016: FDA approves the Raindrop Near Vision Inlay for patients 41 to 65 years old who have not had cataract surgery, with a specific corneal thickness and refractive range.

• 2017 – early 2018: Post-approval study reports and voluntary adverse event filings reveal increasing cases of corneal haze, stromal opacity, melt, and significant uncorrectable vision loss.

• September 2018: The manufacturer, ReVision Optics, issues a worldwide voluntary recall of all lots of the Raindrop Near Vision Inlay.

• October 2018: The FDA publishes a Safety Communication confirming the recall and warning patients and eye care providers about the risk of corneal decompensation and endothelial cell damage.

• 2019 – present: The device has not been re-introduced. No new corneal inlay for presbyopia has received FDA approval to replace it, underlining the regulatory threshold that the Raindrop failed to meet.

(Source: FDA Safety Communication, “Raindrop Near Vision Inlay by ReVision Optics: FDA Safety Communication – Recall Due to Risk of Corneal Decompensation,” October 2018; https://www.fda.gov/medical-devices/safety-communications/raindrop-near-vision-inlay-revision-optics-fda-safety-communication-recall-due-risk-corneal)

Documented Complications That Made the Raindrop Inlay Unsafe

Based on the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database and peer-reviewed case reports, patients with the Raindrop inlay experienced a range of sight-threatening problems. We have seen several of these firsthand when evaluating inlay patients seeking reversal.

• Corneal haze and scarring: A central opacity that reduces contrast sensitivity and best-corrected vision, not fully reversible.

• Endothelial cell loss: The corneal endothelium does not regenerate; accelerated cell loss can lead to chronic corneal edema and the eventual need for a corneal transplant.

• Stromal melt and thinning: A serious condition where the corneal tissue degrades around the inlay, causing irregular astigmatism and instability.

• Inlay dislocation or decentration: Resulting in double images, ghosting, and unpredictable refractive errors.

• Chronic dry eye syndrome: The inlay can disrupt the tear film and corneal nerves, causing intractable discomfort.

• Reduced distance vision in the implanted eye: Many patients lost crisp distance clarity, essentially trading one problem for another.

• Need for explant surgery: Removing the inlay does not guarantee corneal recovery; some eyes retain permanent scarring and irregular shape.

We emphasize that the FDA did not use the term “unsafe” lightly. The recall was categorized as a Class I recall—the most serious type, reserved for devices with a reasonable probability of causing serious adverse health consequences or death.

What Liberty Laser Eye Center Recommends Instead: Non-Implant Presbyopia Correction

At Liberty Laser Eye Center, our guiding principle has always been to preserve corneal integrity while delivering freedom from glasses and contacts. Board-certified ophthalmologist Dr. Nancy Tanchel has performed over 30,000 refractive procedures—more than any other female surgeon in the United States—using FDA-approved, wavefront-optimized laser platforms that treat the cornea’s natural tissue, not insert foreign material.

We offer the following lens-free, no-implant solutions for reading vision:

PresbyLASIK (Custom Blended Vision)

Using our CATz Topography-Guided LASIK technology, we create a gentle multifocal corneal profile without cutting a flap in the traditional sense (our bladeless femtosecond laser creates a precision flap). By optimizing the corneal shape in both eyes, we extend the depth of focus so that one eye sees far and intermediate while the other sees near—an advanced form of blended vision that yields seamless focus from a smartphone to a street sign.

• No implant – only your own remodeled corneal tissue.

• Decades of safety data – LASIK and surface ablation have the longest post-market surveillance in refractive surgery.

• Adjustable – Unlike an inlay that is surgically removed with difficulty, a laser enhancement can fine-tune the result if needed.

• Rapid recovery – Most patients return to work within 24 to 48 hours.

Advanced PRK (Surface Ablation)

For patients with thinner corneas or specific occupational demands, we perform Advanced PRK, which reshapes the corneal surface without creating a flap. This is an excellent option for presbyopia when combined with monovision or mild blended vision.

Monovision LASIK or PRK

A time-tested strategy where the dominant eye is corrected for distance and the non-dominant eye for near. While monovision has been used for decades with contact lenses, our wavefront-guided execution reduces higher-order aberrations and enhances the brain’s ability to fuse the two images into one fluid visual experience.

Unique insight from Dr. Tanchel’s experience: Over the years, we have converted many patients who previously received corneal inlays at outside clinics. By removing the inlay, allowing the cornea to stabilize, and then performing topography-guided PRK, we often can restore not only near vision but improve overall quality of vision beyond what the inlay ever provided. This is possible because our diagnostic technology maps 22,000 unique elevation points on the cornea, enabling personalized correction even on irregular post-inlay surfaces.

Head-to-Head Comparison: Raindrop Inlay vs. Liberty Laser Eye Center’s PresbyLASIK

The table below highlights why, in 2026, the Raindrop inlay remains an unsafe historical footnote and why our laser-based approach is the definitive choice.

This comparison clarifies that a safe reading vision correction should not depend on a device that the body can reject or that damages the inner corneal layer over time.

What to Do If You Currently Have a Raindrop Inlay

We advise patients who still have the implant to take the following steps, which we have found effective in our clinic during countless evaluations:

1. Schedule a comprehensive corneal evaluation with an experienced cornea specialist. You need endothelial cell count measurement (specular microscopy), corneal topography, and a slit-lamp exam to check for haze or thinning.

2. Do not ignore subtle changes. If you notice increased glare, fluctuating vision, or discomfort, early intervention can prevent permanent damage.

3. Discuss explantation candidacy. If the inlay is causing progressive cell loss or vision deterioration, removal may be recommended. Surgery should only be performed by a surgeon with expertise in corneal reconstruction.

4. Plan for visual rehabilitation post-removal. After the cornea has stabilized (typically three to six months), laser vision correction such as topography-guided PRK can often restore functional near and distance vision.

5. Monitor endothelial health annually. Even after explant, regular checks are prudent.

At Liberty Laser Eye Center, we offer no-cost corneal evaluations for former Raindrop patients. We can map the cornea’s true shape and determine if laser correction is feasible. Many patients travel to us from across the Washington Metropolitan Area because of Dr. Tanchel’s unmatched experience with complex refractive cases.

Why Liberty Laser Eye Center Is the Safe Harbor in Fairfax County and Beyond

We designed our practice around trust, technology, and transparency. Here is what you can expect:

• Board-certified expertise: Dr. Nancy Tanchel has performed more than 30,000 laser procedures—more than any other female ophthalmologist in the U.S. She personally examines every patient and creates each treatment plan.

• FDA-approved, wavefront-optimized platforms: Our Custom Bladeless LASIK and CATz Topography-Guided LASIK correct lower- and higher-order aberrations simultaneously, delivering superior night vision and contrast sensitivity.

• No foreign implants for presbyopia: We intentionally avoided corneal inlays because the cornea’s natural optics can be safely enhanced without added materials.

• Convenient care: Our Vienna, VA, location offers a complimentary shuttle from Dunn Loring Metro. We see patients from Fairfax County, the District, Maryland, and beyond.

• Lifetime commitment: We stand behind our outcomes with a commitment to enhancements when indicated, so your investment in vision is protected.

Reach us directly at (571) 234-5678 to book a presbyopia consultation or a post-Raindrop evaluation.

Is the Raindrop Near Vision Inlay still approved by the FDA?

No. The Raindrop Near Vision Inlay was voluntarily recalled by the manufacturer in 2018 following an FDA Safety Communication. The device is no longer commercially available anywhere in the world. Its FDA approval was effectively rescinded through the recall process, and no similar hydrogel inlay has been approved since.

Why was the Raindrop inlay considered unsafe enough for a Class I recall?

A Class I recall denotes a situation where there is a reasonable probability that using the device will cause serious adverse health consequences or death. For the Raindrop inlay, the primary hazards were corneal decompensation (endothelial cell loss leading to chronic swelling), stromal melt, and permanent vision loss that could require corneal transplantation. These complications could progress silently and were not always reversible by removing the implant.

What should I do if I have a Raindrop implant and I’m worried?

We recommend a thorough corneal health assessment that includes endothelial cell counts and topography. At Liberty Laser Eye Center, we offer no-cost evaluations for patients with existing inlays. If explantation is necessary, we can then design a vision restoration plan, often using Advanced PRK once the cornea has healed.

What is the safest alternative to the Raindrop inlay for reading vision in 2026?

The safest alternatives do not require a corneal implant. At Liberty Laser Eye Center, we perform PresbyLASIK (custom blended vision), monovision LASIK, and Advanced PRK. These laser procedures reshape your own corneal tissue without introducing foreign material, entirely eliminating the risk of implant-related endothelial damage, haze, or rejection.

Does Liberty Laser Eye Center ever use corneal inlays?

No. Our practice philosophy has always been to work with the eye’s natural optics. Dr. Tanchel decided against offering any corneal inlay after evaluating the early science and concluding that the long-term corneal health risks outweighed the near-term reading improvement. We are a no-implant presbyopia correction center.

Can a failed Raindrop inlay be fixed with laser eye surgery?

Often, yes. We have successfully treated many post-explant patients using topography-guided PRK. Once the cornea stabilizes, we map every irregularity and apply a custom laser treatment that regularizes the surface and reduces or eliminates the need for glasses. Outcomes depend on the residual corneal thickness and endothelial health, which we carefully assess during the consultation.

How much does presbyopia laser treatment cost at Liberty Laser Eye Center?

Our all-inclusive pricing for PresbyLASIK or blended vision LASIK is provided after a personalized diagnostic evaluation. We discuss every cost transparently during the consultation, and we never charge hidden fees. Patients can use health savings accounts and flexible spending dollars. We invite you to call (571) 234-5678 to schedule your appointment and learn about current pricing.

Is there public transportation to Liberty Laser Eye Center?

Yes. We provide a free shuttle from the Dunn Loring Metro station. Our Vienna, VA, office is easily accessible from the entire Washington Metropolitan Area, including Fairfax County, Arlington, Alexandria, and Bethesda.

See clearly, live freely—without an implant, without compromise. Book your comprehensive consultation at Liberty Laser Eye Center by calling (571) 234-5678 or visiting our Vienna office. Trust the surgeon who has performed more laser vision correction procedures than any other female ophthalmologist in the United States and who never placed a recalled corneal inlay.