AcrySof™ IQ Vivity™ DFT615 (REF DFT615.250)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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652423380), received between Oct 3, 2022 and May 22, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Crack” (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.
Most reported problems
Device problems
- Crack1
- Defective Component1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2023Defective Component; Defective Component
A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LOWER HAPTIC OF IOL WAS DAMAGED AFTER IMPLANTATION. THE LENS WAS LEFT IN SIDE THE EYE. THE SURGEON WAS PLANNED TO EXPLANT THE LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE IOL WAS EXPLANTED IN SECONDARY PROCEDURE. AS PER THE SURGEONS OPINION, THE INTRODUCER DAMAGED THE LENS BECAUSE THE LENS WAS A TORIC LENS AND THICKER THAN NORMAL. THE RECOMMENDED CARTRIDGE COULD HAVE HELPED PRIOR TO THE SURGERY TO PREVENT THE DAMAGE TO THE LENS.
Patient problems: Insufficient Information
MAUDE report 16972501 ↗MalfunctionOct 3, 2022Crack; Crack
AN INTRAOCULAR LENS (IOL) WAS RETURNED TO COMPANY WITH A DESCRIPTION OF CRACK IN IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15528388 ↗
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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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