AcrySof™ IQ Vivity™ DAT615 (REF DAT615.175)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV ABSORBING 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652426220), received between May 24, 2022 and May 24, 2022 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blurred Vision1
- Corneal Edema1
- Intraocular Pressure Increased1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED CORNEAL EDEMA AND A RISE IN THE INTRAOCULAR PRESSURE. THE PATIENT HAD ALSO COMPLAINED ABOUT POOR VISION THREE DAYS POST OPERATIVE. ONE WEEK POST OPERATIVE THE PATIENT COMPLAINED ABOUT VISION NOT AS SHARP AS HW WOULD LIKE IT TO BE AND STATES THAT THERE WAS NO MAJOR IMPROVEMENT IN THE VISION. FELT THE VISION WAS BETTER OUT OF THE OTHER EYE WITH SPECS ON THAN THE SURGERY EYE. THERE WAS NO DISCOMFORT OR IRRITATION. THE INTRAOCULAR PRESSURE WAS NORMAL ONE WEEK POST SURGERY. PATIENT UNCORRECTED DISTANCE VISION IS SATISFACTORY AND THE PATIENT WAS PLEASED WITH THE VISUAL OUTCOME. THE PATIENT IS ALSO CONSIDERING AN LENS EXCHANGE FOR THE LEFT EYE AS THE LENS WAS TOO STRONG. ADDITION INFORMATION HAS BEEN RECEIVED STATING THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE.
Patient problems: Blurred Vision; Corneal Edema; Intraocular Pressure Increased; Visual Impairment
MAUDE report 14485867 ↗
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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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