AcrySof™ IQ Vivity™ DFT615 (REF DFT615.245)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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652423373), received between May 20, 2022 and May 20, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
Patient problems
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN OTHER HEALTH CARE REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE POSTOPERATIVE RESULT ENDED UP IN THE MINUS TOO MUCH FOR THE PATIENT. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. THE CYLINDER CAN BE MINIMIZED, BUT THE SPHERE REMAINS TOO MYOPIC. THE PATIENT WAS SIGNIFICANTLY BETTER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SAME REPORTED THAT, IT WAS DETERMINED THAT THE LENSES HAVE LANDED TOO FAR IN THE MINUS DUE TO TILTING AND CALCULATION ISSUE. THE PATIENT WAS SATISFIED AFTER EXCHANGE BUT VISION WAS STILL SLIGHTLY BLURRED.
Patient problems: Visual Impairment
MAUDE report 14462051 ↗
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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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