AcrySof™ IQ Vivity™ DFT615 (REF DFT615.125)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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652423137), received between Mar 11, 2022 and May 28, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Align” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Failure to Align1
Patient problems
- Blurred Vision1
- Insufficient Information1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT AFTER SURGERY THE PATIENT HAS EXPERIENCED A POST-OPERATIVE ASTIGMATISM WITH 2.5 DIOPTERS. ADDITIONALLY, PATIENT ALSO HAD HER BLURRED VISION DUE TO THE HUGE AMOUNT OF RESIDUAL ASTIGMATISM. THE WHOLE PLAN (BIOMETRY., ETC.) OF THE SURGERY HAS BEEN DONE WITH A PROPERLY CALIBRATED WITH COMPANY BIOMETRY. ALTHOUGH POSTOPERATIVELY THE PATIENT NEEDS GLASSES IN ORDER TO CORRECT THIS RESIDUAL ASTIGMATISM. POST OPERATIVELY EXAMINATION SHOWN THAT NO ROTATION AND NO DECENTRATION OF THE INTRAOCULAR LENS (IOL) AND THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 22096872 ↗InjuryMar 11, 2022Failure to Align; Failure to Align
A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS HAS ROTATED FROM 105 DEGREES TO 60 DEGREES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED WHICH CONFIRMS THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 13734821 ↗
Other Extended depth of focus intraocular lens devices
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- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens1 recall49 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens93 reports
- 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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