AcrySof™ IQ Vivity™ DFT315 (REF DFT315.165)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV and Blue Light Filtering Acrylic Foldable Aspheric Wavefront-Shaping Toric Posterior Chamber Intraocular Lenses · Class 3 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652421577), received between Oct 12, 2021 and Apr 23, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Failure to Deliver1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2025Failure to Deliver; Failure to Deliver
A PHARMACIST REPORTED WITH A DESCRIPTION OF IMPLANT STUCK IN THE INJECTOR. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21889515 ↗InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT APPROXIMATELY AFTER A MONTH OF IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE LENS WAS EXPLANTED WITH A PATIENT AND CLINICAL REASON OF DOUBLE VISION. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 15752809 ↗MalfunctionMar 9, 2022Positioning Failure; Positioning Failure
A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THERE WAS AN ISSUE WITH PLACEMENT. THE PRODUCT WAS IN CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO HARM TO THE PATIENT AND WAS NOT HOSPITALIZED FOR THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13708710 ↗MalfunctionOct 12, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED WHICH STATES THAT DESPITE PARA-CENTRAL GLISTENINGS PERSISTING UNCHANGED, THE PATIENT IS SYMPTOM FREE AND HAPPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12618841 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.