AcrySof™ IQ Vivity™ DFT615 (REF DFT615.195)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV AND BLUE LIGHT FILTERING ACRYLIC FOLDABLE ASPHERIC X-WAVE™ POSTERIOR CHAMBER INTRAOCULAR LENS · Class 3 · Implant
All models of AcrySof IQ Vivity (225)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652423274), received between Aug 16, 2023 and Aug 16, 2023 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Glaucoma1
- Inflammation1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN OPHTHALMIC SURGEON REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT COMPLAINED OF EXPERIENCING CENTRAL SCOTOMA (CENTRAL VISION LOSS), BUT ONCE THE LIGHTS WERE TURNED ON, EVERYTHING WENT BACK TO NORMAL, PATIENT COULD SEE EVERYTHING. THE PATIENT WAS SEEING BLACK CIRCLES IN FRONT OF THE VISUAL FIELD UPON AWAKENING FROM SLEEP FROM THE PAST 2 WEEKS. THE SURGEON TOLD THAT THE LENS WAS PERFECTLY CENTERED, VISION WAS GOOD INITIALLY AFTER CATARACT SURGERY WAS DONE. THE INTRAOCULAR LENS (IOL) HAD NO DEFECT OR DAMAGE. YTTRIUM-ALUMINUM-GARNET (YAG) LASER WAS DONE TO CLEAR ANY LEVEL OF POSTERIOR CAPSULE OPACITY (PCO). THE PATIENT HAD NONEXUDATIVE AGE-RELATED MACULAR DEGENERATION (ARMD) (EARLY DRY STAGE), YET EXAMINATION IMAGES SHOWED THAT IT WAS NOT ADVANCED AND ALL THE SURGEONS WHO HAD CHECKED THE CASE SAID THAT ARMD IS NOT THE CAUSE FOR THE SCOTOMA. THE CLINICAL EXAMINATION DONE AFTER IMPLANTATION ALSO REVEALED THAT THE PATIENT HAD TOXIC MACULOPATHY, GLAUCOMA SECONDARY TO EYE INFLAMMATION (INDETERMINATE STAGE). ADDITIONAL INFORMATION RECEIVED STATED THAT THE LENS REMAINS IMPLANTED IN THE PATIENT'S EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. T
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Glaucoma; Inflammation; Visual Impairment
MAUDE report 17554661 ↗
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- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens89 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens87 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens75 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens73 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens71 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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