AcrySof™ IQ Vivity™ DAT315 (REF DAT315.170)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV Absorbing Acrylic Foldable Aspheric Wavefront-Shaping Toric Posterior Chamber Intraocular Lenses · Class 3 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652427036), received between Apr 2, 2021 and Oct 6, 2022 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Malposition of Device” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
- Malposition of Device1
Patient problems
- Blurred Vision2
- Visual Impairment2
- Conjunctivitis1
- Corneal Edema1
- Inflammation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD EDEMA, INFLAMMATION AND CONJUNCTIVITIS CHEMOSIS WHICH LED TO DECREASED VISION POSTOPERATIVELY. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Blurred Vision; Conjunctivitis; Corneal Edema; Inflammation
MAUDE report 15550777 ↗MalfunctionJan 17, 2022Malposition of Device; Appropriate Device Problem Term/Code Not Available; Malposition of Device; Appropriate Device Problem Term/Code Not Available
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS ROTATED 70 DEGREES OUT OF POSITION. THE PATIENT HAD WRONG IOL POWER AND THE LENS WAS PLANNED TO EXCHANGED FOR ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED AND PROVIDED THAT THERE WAS NOTHING WRONG WITH THE ORIGINAL 17.0 D INTRAOCULAR LENS PLACED INTO LEFT EYE ON 12-6. I REALIZED LATER IN THE EVENING ON 12-6 THAT I HAD TRANSPOSED ORDERS FOR RIGHT AND LEFT EYE. TORIC INTRAOCULAR LENS WAS IN GREAT POSITION AT TARGET AXIS AT DAY ONE POST OPERATION AND VISION CORRECTED TO 20/20 WITH +0.50 SPHERE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 13266539 ↗InjuryApr 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS PROVIDED THAT THERE WAS NO PATIENT HARM AND THE PATIENT'S ISSUES HAVE RESOLVED.
Patient problems: Visual Impairment
MAUDE report 11608597 ↗
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- 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.