ACRYSOF® SA60AT (REF SA60AT.230)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
Quick summary
This Alcon AcrySof SA60AT is a foldable artificial lens implanted in the eye during cataract surgery. The 38 reports mostly describe the lens breaking, scratching, or tearing while being loaded or unfolded in surgery, sometimes forcing the surgeon to swap in a different lens, plus follow-up reports of eye inflammation, pain, redness, and distorted vision. There were no deaths and 11 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00380652555869), received between Apr 20, 2021 and May 4, 2026 — classified as 10 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Break5
- Defective Device5
- Scratched Material5
- Material Split, Cut or Torn3
- Product Quality Problem3
- Crack2
- Device Damaged by Another Device2
Patient problems
- Insufficient Information17
- No Clinical Signs, Symptoms or Conditions12
- Capsular Bag Tear3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Endophthalmitis1
- Inflammation1
- Intraocular Pressure Increased1
- Pain1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2026Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC WAS UNUSABLE SINCE IT GOT STUCK BEHIND THE LENS, WAS ROLLED UP ONTO ITSELF, AND WAS UNABLE TO LOAD. THE LENS WAS NOT IMPLANTED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25066849 ↗MalfunctionApr 3, 2026Product Quality Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEFECTIVE. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24777540 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT COMPLAINT OF PAIN, REDNESS AND VISION DISTORTION. PATIENT WAS ON ANTI-GLAUCOMA MEDICATION WITH CURRENT IOP AS 17.
Patient problems: Intraocular Pressure Increased; Pain; Visual Disturbances
MAUDE report 24518732 ↗MalfunctionMar 2, 2026Product Quality Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECT IN THE LENS. THERE WAS NO PATIENT HARM AND NO DELAY IN SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482480 ↗MalfunctionJan 16, 2026Device Damaged by Another Device
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE PUSHING WITH THE INJECTOR LENS HAPTIC WAS FRACTURED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH UNSPECIFIED REPLACEMENT LENS.
Patient problems: Insufficient Information
MAUDE report 24094150 ↗MalfunctionJan 13, 2026Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IOL MALFUNCTIONED DURING THE IMPLANTATION. THE LENS BROKE AND COULD NOT BE USED. THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24050715 ↗InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, VITREOUS INFLAMMATION OCCURRED WITHIN THE FIRST WEEK AFTER SURGERY. THE PATIENT WAS CURRENTLY UNDERGOING TREATMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Inflammation
MAUDE report 23451495 ↗MalfunctionJul 1, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING INSERTION INTO THE RIGHT EYE, THE LENS BROKE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22370430 ↗MalfunctionJun 12, 2025Failure to Deliver; Device Damaged by Another Device; Failure to Deliver; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING PHAKIC INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK IN THE CARTRIDGE. IT BECAME DEFORMED AND UNUSABLE. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22195593 ↗InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, LENS WAS IMPLANTED BRIEFLY. IT WAS THEN QUICKLY EXPLANTED AND REPLACED WITH A THREE PIECE LENS. WHEN THE LENS WENT IN THAT IT ¿FELL¿ AND AFTER EXAMINING THE BAG, NOTICED THERE WAS A SMALL HOLE. VITRECTOMY WAS USED TO CLEAN UP THE AREA AND ANOTHER COMPANY LENS WAS USED. HE HAD PREVIOUSLY BROUGHT ONE IN JUST IN CASE IT WAS NEEDED. IT DIDN¿T PRESENT UNTIL AFTER THE LENS WAS IN. DOCTOR DID NOT BELIEVE THAT THE LENS CAUSED THE HARM. JUST DIDN¿T PRESENT UNTIL AFTER IT WAS IN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 22046151 ↗MalfunctionApr 18, 2025Break; Break
A HEALTH CARE PROFESSIONAL DURING SURGERY NOTICED THAT THE LENS APPEARED WITH POOR INFERIOR HAPTICS, WHICH WAS EVIDENT AT THE TIME OF LENS INJECTION. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS WITH SAME POWER. THE PATIENT WAS IN GOOD CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21863968 ↗MalfunctionApr 2, 2025Product Quality Problem; Product Quality Problem
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS THAT HAS A SMALL DEFECT NOTED AFTER BEING INSERTED INTO THE EYE. THEY TOOK THE INSERTER OUT OF ROTATION AND FLAGGED IT. THE LENS WAS EXPLANTED IN THE INITIAL PROCEDURE AND PATIENT DID WELL WITHOUT ANY COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21755889 ↗MalfunctionFeb 24, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS POPPED OFF. THE LENS ENTERED OR TOUCHED THE PATIENT EYE AND A SECOND LENS WAS USED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE LENS WAS NOT INSERTED AND REMOVED OR LEFT IMPLANTED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21445667 ↗MalfunctionFeb 13, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED A SCRATCH ON INTRAOCULAR LENS AFTER IMPLANTATION. THE LENS WAS REMOVED DURING INITIAL PROCEDURE. THE SURGERY WAS COMPLETED WITH THE ANOTHER UNSPECIFIED IOL ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21374149 ↗MalfunctionJan 6, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A SCRATCH ON LENS AFTER INSERTION. THE LENS WAS LEFT IN EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21078821 ↗MalfunctionNov 15, 2024Defective Device; Defective Device
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, LENS WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20696471 ↗InjuryNov 14, 2024Material Discolored; Material Discolored
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, EXPLANTED AN IOL THAT WAS IMPLANTED IN ONE OF THE PATIENT IN 2019. LENS HAS CHANGED COLOR IN THE EYE OF THE PATIENT AND THE SURGEON HAS REMOVED THE LENS FROM THE PATIENTS EYE. THE LENS WAS EXCHANGED 05 YEARS 04 MONTHS FOLLOWING THE INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 20688545 ↗MalfunctionNov 13, 2024Defective Device; Defective Device
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IOL INSERTION, DAMAGE TO THE EDGE OF THE OPTIC WAS NOTICED.THERE WAS NO PATIENT HARM.THE PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20671583 ↗MalfunctionNov 12, 2024Defective Component; Defective Component
A SURGEON REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTATION THE SURGEON NOTICED THAT THE TWO HAPTICS ARE IN THE POSTERIOR SIDE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20666247 ↗InjurySep 18, 2024Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC FRACTURED. THE LENS WAS REMOVED DURING THE INITIAL PROCEDURE AND REPLACED WITH ANOTHER LENS. THERE WAS A RUPTURE OF THE POSTERIOR CAPSULE DURING THE PROCESS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT ANTERIOR VITRECTOMY WAS PERFORMED, AND AN UNSPECIFIED THREE-PIECE LENS WAS IMPLANTED. PATIENT WAS PRESCRIBED WITH ANTIBIOTIC AND STEROID ANTI-INFLAMMATORY AS A POST-SURGICAL MANAGEMENT. PATIENT'S OUTCOME WAS RECOVERED.
Patient problems: Capsular Bag Tear
MAUDE report 20249597 ↗MalfunctionJul 29, 2024Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED SCRATCH ON THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19850383 ↗InjuryApr 4, 2024Material Opacification; Material Opacification
A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF INTRAOCULAR LENS (IOL) GOT OPAQUE WHICH WAS IMPLANTED IN THE YEAR 2007. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 19040243 ↗MalfunctionJan 10, 2024Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT'S VISION WAS NORMAL DURING THE POST OPERATIVE VISITS. DURING DECEMBER, WHEN THE PATIENT VISITED THE PHYSICIAN FOR THE POST OPERATIVE VISIT, THE PHYSICIAN SUSPECTED A SCRATCH ON THE SURFACE OF THE LENS, WHICH WAS IDENTIFIED UNDER THE SLIT LAMP. HOWEVER, THE PATIENT'S VISION WAS STILL NORMAL.
Patient problems: Insufficient Information
MAUDE report 18482095 ↗MalfunctionDec 11, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF BUBBLE IN INTRAOCULAR LENS (IOL). NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18300036 ↗InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, WHEN THE DOCTOR PUT THE LENS IN THE BAG, THE CAPSULE RUPTURED. THE CASE WAS DISCUSSED WITH THE DOCTOR AND TRIAMCINOLONE WAS INJECTED. THE PRESENCE OF VITREOUS WAS VERIFIED AND ANTERIOR VITRECTOMY WAS INITIATED. IT WAS CONFIRMED THAT THERE WAS NO POSTERIOR CAPSULAR SUPPORT, THEREFORE, THE LENS WAS CUT AND REMOVED AND REPLACED WITH A COMPANY LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Capsular Bag Tear
MAUDE report 18299821 ↗
Other intraocular lens devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.