AcrySof™ IQ Vivity™ DFT015 (REF DFT015.115)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV and Blue Light Filtering Acrylic Foldable Aspheric Wavefront-Shaping 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 00380652421065), received between Mar 14, 2023 and Mar 14, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL FOUND TO HAVE DEPOSITS ON IT. HEALTH CARE PROFESSIONAL WAS ABLE TO ASPIRATE THE MATERIAL. IT WAS STATED THAT PRESUMABLY, SOME MATERIAL DETACHES FROM THE LENS DURING SHOOTING AND THEN LIES DOWN ON THE FRONT SURFACE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING AFTER IMPLANTATION, SLIGHT SCRATCHES WERE VISIBLE ON THE IOL OPTICS. THIS WAS POLISHED OUT USING THE BIMANUAL SURGICAL TECHNIQUE. THE SURGERY WAS ALSO COMPLETED ON THE SAME DAY. THERE WAS NO HARM TO THE PATIENT AND NO INTERVENTION WAS NEEDED. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND NO PATIENT IMPAIRMENT WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16536740 ↗
Other Extended depth of focus intraocular lens devices
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens101 reports
- 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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