AcrySof™ IQ Vivity™ DAT415 (REF DAT415.250)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV Absorbing Acrylic Foldable Aspheric Wavefront-Shaping Toric Posterior Chamber Intraocular Lenses · 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 00380652428019), received between Apr 27, 2022 and Apr 27, 2022 — 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
- Corneal Abrasion1
- Halo1
- Visual Disturbances1
- Visual Impairment1
- Vitreous Floaters1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD A SUPERIOR CORNEAL EPITHELIAL EROSION. SO SURGEON PLACED A BANDAGE CTL¿S (CONTACT LENS) FOR THE FIRST WEEK. AT DAY 10 PATIENTS VISION WAS POOR AT ALL DISTANCES ALTHOUGH EYE LOOKED GOOD WITH IOL AXIS 170. SHE COULD NOT READ ANYTHING NEAR OR INTERMEDIATE. SHE WAS 20/50 DISTANCE SC (WITHOUT CORRECTION) REFRACTING TO 20/30 +2 WITH +0.75. THE SURGEON TOOK HER TO THE MINOR ROOM AND REPOSITIONED THE IOL TRYING TO SHIFT TOWARDS 178 AND REVERSE OPTIC CAPTURED IT TO INCREASE THE EFFECTIVE LENS POWER. A FEW DAYS LATER SHE WAS 20/25 DISTANCE SC AND REFRACTING WITH LOW MYOPIA. AT ONE MONTH POST SHE WAS 20/30+2 DISTANCE SC AND J5 INTERMEDIATE AND NO REFRACTIVE ERROR ON EXAM. ADDED FREQUENT ARTIFICIAL TEARS AND WAIT A MONTH. AT 8 WEEKS, THE POSTERIOR CAPSULE WAS QUITE OPACIFIED EARLY DUE TO THE ROC (RETINOL CORREXION EYE CREAM). THE PATIENT WAS COMPLAINING OF GLARE, BLURRY HALO AND PHOTOPHOBIA WHICH THE SURGEON PRESUMED WAS DUE TO THE CAPSULE SO A YAG (YTTRIUM ALUMINUM GARNET) CAPSULOTOMY WAS PERFORMED. AT THE NEXT VISIT AROUND 90 DAYS POST OP SHE WAS 20/25 + WITH NO SIGNIFICANT REFRACTIVE ERROR BUT COM
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Abrasion; Halo; Visual Disturbances; Visual Impairment; Vitreous Floaters
MAUDE report 14219750 ↗
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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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