ACRYSOF® SA60AT (REF SA60AT.170)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) SINGLE-PIECE ACRYLIC FOLDABLE IOL,UV-ABSORBING POSTERIOR CHAMBER LENS (IOL/PC),13.0mm LENGTH, 6.0mm BICONVEX OPTIC, PLANARHAPTICS. · Class 3 · Implant
All models of ACRYSOF (353)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652555746), received between Sep 24, 2021 and Apr 24, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Defective Device” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Defective Device2
- Device Dislodged or Dislocated2
- Break1
Patient problems
- Insufficient Information3
- Blurred Vision1
- Visual Disturbances1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2026Break
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IOL WAS LOADED AND SURGEON INSERTED IOL INTO THE EYE. UPON POSITIONING, THE SURGEON IDENTIFIED A MISSING TRAILING HAPTIC. THE LENS WAS EXPLANTED AND REPLACED DURING THE SAME PROCEDURE. THE DETACHED HAPTIC FRAGMENT WAS LATER LOCATED ON THE STERILE FIELD. MECHANISM OF BREAKAGE WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 24987443 ↗MalfunctionMay 20, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED WITH DESCRIPTION DEFECTIVE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19352515 ↗MalfunctionJul 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT STATED HIS LENS DISLOCATED. HE DENIED ANY TRAUMA TO INJURY THAT WOULD HAVE POTENTIALLY DISLODGED IT. HE WOKE UP AND NOTICED WHEN WATCHING TV HE HAD DOUBLE VISION. HE SAW PHYSICIAN AND WAS TOLD LENS WAS DISLOCATED AND WOULD NEED TO BE REMOVED/REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 17340479 ↗MalfunctionJan 10, 2023Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED OF A DEFECTIVE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16129622 ↗InjurySep 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTER STATING PATIENT ISSUES WERE RESOLVED AND THERE WAS NO PATIENT HARM. THE PATIENT'S VISION QUALITY WAS IMPROVED.
Patient problems: Blurred Vision
MAUDE report 12527559 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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.
How reports and recalls are matched · Editorial policy · Report an error on this page