ACRYSOF® SA60AT (REF SA60AT.195)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
- 16
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00380652555791), received between Mar 25, 2021 and Dec 15, 2025 — classified as 2 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (3 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
- Failure to Deliver3
- Scratched Material3
- Adverse Event Without Identified Device or Use Problem2
- Crack2
- Material Split, Cut or Torn2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Defective Device1
Patient problems
- Insufficient Information11
- No Clinical Signs, Symptoms or Conditions3
- Capsular Bag Tear2
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON FOUND SEVERAL CRACKS ON IOL PERIPHERAL. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23803655 ↗MalfunctionSep 19, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) STUCK IN CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23095854 ↗MalfunctionAug 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED AFTER INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTING THE IOL IN THE EYE THE SURGEON NOTICED THERE WAS A CRACK ON THE LENS. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22806713 ↗MalfunctionMay 23, 2025Product Quality Problem; Failure to Deliver; Product Quality Problem; Failure to Deliver
A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REPORTED THAT THE LENS WAS DEFORMED BECAUSE IT WAS STUCK IN THE CARTRIDGE, IT WAS STATED THAT THERE WAS NO PATIENT CONTACT AND NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22076621 ↗MalfunctionApr 18, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21865599 ↗MalfunctionApr 17, 2025Scratched Material; Scratched Material
NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21860717 ↗MalfunctionFeb 10, 2025Failure to Deliver; Material Twisted/Bent; Failure to Deliver; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING CATARACT WITH INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS JAMMED AND DID NOT ENGAGE AND THERE WAS SOME PROBLEM WITH HAPTIC. THERE ARE SIX FILES ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 6.
Patient problems: Insufficient Information
MAUDE report 21343807 ↗MalfunctionJan 3, 2025Break; Break
A NURSE STATED THAT HAPTIC WAS BROKEN.
Patient problems: Insufficient Information
MAUDE report 21065425 ↗MalfunctionMar 20, 2024Material Discolored; Material Discolored
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS TRANSLUCENT IN COLOR AND NOT TRANSPARENT. ADDITIONAL INFORMATION WAS REQUESTED, AND RECEIVED STATING THE IOL WAS REPLACED WITH OTHER COMPANY LENS IN A INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 18940484 ↗MalfunctionFeb 16, 2024Defective Device; Defective Device
AN OTHER HEALTH CARE PROFESSIONAL REPORTED A DAMAGED INTRAOCULAR LENS (IOL). THE IOL WAS NOT IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18719613 ↗InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT AT THE TIME OF IMPLANTING, WHEN THE LENS ENTERS THE CAPSULAR BAG, IT IS OBSERVED THAT HE DOES NOT HAVE A CAPSULAR SUCTION, WHICH IS WHY A LENS EXPLANT SHOULD BE PERFORMED AND A CHANGE MADE TO A 3-PIECE LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED, STATING THAT THE PATIENT HAD RECOVERED AND THAT THE SURGERY THAT WAS BEING PERFORMED AT THE TIME OF THE EVENT WAS PHACOEMULSIFICATION.
Patient problems: Capsular Bag Tear
MAUDE report 17172964 ↗InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
UPON REVIEW OF INITIALLY RECEIVED INFORMATION, EVENT OUTCOME HAS BEEN UPDATED FROM MALFUNCTION TO OTHER MEDICALLY SIGNIFICANT EVENT.
Patient problems: Capsular Bag Tear
MAUDE report 16808277 ↗MalfunctionJul 14, 2022Scratched Material; Scratched Material
A NURSE REPORTED THAT THERE WAS SCRATCHES ON THE OPTICS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15011070 ↗MalfunctionMay 9, 2022Crack; Crack
A NON HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS HAD A CRACK ON IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14340754 ↗MalfunctionDec 29, 2021Crack; Crack
A FACILITY REPRESENTATIVE REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE SURGEON LOADED LENS IN CARTRIDGE AND INSERTED IN CORNEA. SURGEON OBSERVED THAT THE LENS WAS CRACKED AND REMOVED WITH FORCEPS. THE SURGERY WAS COMPLETED BY A BACKUP LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13112353 ↗MalfunctionMar 25, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED UPON IMPLANTING AN INTRAOCULAR LENS (IOL), A SURGEON NOTICED SOME CRYSTAL LOOKING MATERIAL ON THE OPTIC. THE SURGEON ATTEMPTED TO REMOVE THE MATERIAL BUT IT DID NOT COME OFF OF THE LENS. THE LENS WAS THEN REMOVED DURING THE INITIAL PROCEDURE AND A BACKUP LENS WAS IMPLANTED. THERE WAS NO REPORTED PATIENT IMPACT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11568995 ↗
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