ACRYSOF® SA60AT (REF SA60AT.260)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
- 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 00380652555920), received between Apr 4, 2024 and Mar 13, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Adverse Event Without Identified Device or Use Problem1
- Device Damaged by Another Device1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Blurred Vision1
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2026Break
A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS LEG WAS BROKEN. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24590978 ↗MalfunctionAug 30, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A NURSE REPORTED THAT DURING SURGERY THE SURGEON NOTICED A DETACHED HAPTIC AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED. THE DAMAGED IOL WAS THEN REMOVED IN AN INITIAL PROCEDURE. ACCORDING TO ADDITIONAL INFORMATION RECEIVED ON 30-JUL-2024, AFTER IMPLANTING THE LENS INTO THE EYE, IT TURNED OUT THAT THE LENS WAS DAMAGED - THE OPTICS WERE BROKEN. THE LENS WAS REMOVED AND NEW COMPANY LENS WAS IMPLANTED IN AN INITIAL PROCEDURE. THERE WAS NO PATIENT IMPACT, JUST THE SURGERY WAS DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20108481 ↗InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED AND THE LENS WAS REPLACED WITH ANOTHER LENS MODEL 02 DAYS FOLLOWING THE INITIAL PROCEDURE.
Patient problems: Blurred Vision
MAUDE report 19296906 ↗MalfunctionApr 4, 2024Device Damaged by Another Device; Device Damaged by Another Device
A NURSE REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THE INJECTOR DAMAGED THE HAPTIC PART - THE BASE OF THE "LEG". THE DAMAGED LENS WAS REMOVED AND A NEW LENS WAS IMPLANTED IN AN INITIAL PROCEDURE. THE PROCEDURE WAS SIGNIFICANTLY PROLONGED DUE TO THE NEED TO REMOVE THE DEFECTIVE LENS.
Patient problems: Insufficient Information
MAUDE report 19039760 ↗
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.
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