ACRYSOF® SA60AT (REF SA60AT.205)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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon AcrySof SA60AT is a foldable acrylic lens implanted in the eye during cataract surgery. The 26 reports mostly describe damage to the lens itself: scratched surfaces, cracked or broken optic and haptic parts, and haptics that bent or would not fold properly, along with one report of calcification and a torn capsular bag. Three reports describe injuries. No recalls name this lens.
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
- 26
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00380652555814), received between Feb 24, 2016 and Dec 22, 2025 — classified as 3 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (9 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
- Scratched Material9
- Break3
- Device Contamination with Chemical or Other Material2
- Failure to Fold2
- Material Split, Cut or Torn2
- Material Twisted/Bent2
- Adverse Event Without Identified Device or Use Problem1
- Defective Component1
Patient problems
- Insufficient Information13
- No Clinical Signs, Symptoms or Conditions10
- Capsular Bag Tear2
- Foreign Body In Patient1
- Hemorrhage/Blood Loss/Bleeding1
- Loss of Vision1
- Visual Impairment1
- Vitreous Floaters1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED A CAPSULE RUPTURE IN THE PATIENT. THE PHYSICIAN REMOVED THE LENS AND REPLACED WITH A THREE-PIECE COMPANY LENS. ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT HARM.
Patient problems: Capsular Bag Tear
MAUDE report 23864857 ↗MalfunctionDec 15, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAPTIC WAS BROKEN. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23809877 ↗MalfunctionNov 19, 2025Material Deformation; Material Deformation
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IMPLANTED LENS APPEARED DAMAGED UPON VISUALIZATION. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE LENS WAS LEFT IMPLANTED IN THE EYE.
Patient problems: Insufficient Information
MAUDE report 23594667 ↗MalfunctionOct 16, 2025Break; Break
A PHYSICIAN REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN WITH NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23315769 ↗MalfunctionAug 21, 2025Material Opacification; Material Opacification
A PHYSICIAN REPORTED THAT IOL CALCIFICATION WAS NOTICED IN ONE OF THE CASE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS OBSERVED LENS HAD CALCIFICATION. THE LENS WAS PLANNED TO EXPLANT FROM PATIENT EYE.
Patient problems: Insufficient Information
MAUDE report 22860469 ↗MalfunctionAug 5, 2025Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS OBSERVED THAT, THERE WERE DENTS ON THE OPTICAL EDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22717157 ↗MalfunctionMay 13, 2025Failure to Fold; Material Twisted/Bent; Failure to Fold; Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BENT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE LENS NEVER GOT FOLDED. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22012067 ↗MalfunctionApr 2, 2025Failure to Fold; Material Split, Cut or Torn; Failure to Fold; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS WAS CRACKED. NURSE FELT UNDUE RESISTANCE WHEN ADVANCING THE LENS TO THE FOLDED POSITION, LENS DID NOT SIT IN FOLDED POSITION FOR LONGER THAN 3 MINUTES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21755891 ↗MalfunctionMar 6, 2025Scratched Material; Scratched Material
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY SCRATCH OR MARK ON OPTIC WAS NOTICED. PROCEDURE COMPLETED ON THE SAME DAY. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21535094 ↗MalfunctionFeb 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NURSE REPORTED BEFORE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS OPENED, WHICH SUBSEQUENTLY BROKE BEFORE BEING PLACED ON THE PATIENT. LENS CANNOT BE USED AND WAS REPLACED BY ANOTHER OF THE SAME MODEL AND DIOPTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21312505 ↗MalfunctionNov 22, 2024Material Discolored; Material Discolored
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE LENS WAS IMPLANTED NOTICED OPAQUE ON LENS. LENS WAS EXPLANTED IN INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20755692 ↗MalfunctionOct 25, 2024Material Twisted/Bent; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, HAPTIC WOULD NOT LAY RIGHT. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20536436 ↗MalfunctionJul 20, 2024Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS IS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19787005 ↗MalfunctionJul 2, 2024Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTATION OF IOL NOTICED SCRATCH ON IOL. LENS WAS EXPLANTED IN A INITIAL PROCEDURE LENS CUTTERS WAS USED TO REMOVED THE IOL. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19656030 ↗MalfunctionMar 5, 2024Scratched Material; Scratched Material
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT LENS WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18834937 ↗MalfunctionNov 24, 2023Scratched Material; Scratched Material
MalfunctionNov 17, 2023Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH WAS FOUND IN THE OPTICAL AREA OF THE LENS. THIS SURGERY WAS COMPLETED WITH NORMAL LENS.
Patient problems: Insufficient Information
MAUDE report 18158399 ↗MalfunctionApr 4, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, AFTER LENS PLACEMENT, NOTED A THREAD ON THE OPTIC. THE THREAD CAME OFF AFTER LONG POLISHING.
Patient problems: Insufficient Information
MAUDE report 16672107 ↗MalfunctionMar 15, 2023Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED THE IOL FOUND TO BE DEFECTIVE NO FURTHER INFORMATION EXPECTED AS REPORTER WAS UNWILLING FOR FOLLOW UP.
Patient problems: Insufficient Information
MAUDE report 16545462 ↗MalfunctionFeb 9, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE BLUE OR WHITE THREADS STUCK TO THE IOLS. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR FOUR OF FOUR.
Patient problems: Insufficient Information
MAUDE report 16337852 ↗InjuryJan 20, 2023Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT STATED THAT, IOL HAD BROKEN HAPTIC AND IS SUBLUXATE IN THE BAG. THE LENS SHIFTS IN THE EYE CAUSING BLEEDING AND EXCESSIVE FLOATERS AND LACK OF VISION. THE PATIENT STATED THAT HER VISION WAS GREAT BEFORE LENS DISLOCATED. PATIENT STATES IT OCCURRED ABOUT A YEAR AND A HALF AGO, SHE WENT TO EMERGENCY AND WAS SENT HOME WITH NO RESOLUTION. SHE HAS PRE-EXISTING GRANULAR DYSTROPHY OF THE CORNEA. SHE SEES 2 CORNEA SPECIALISTS AND HAS ALSO SEEN A RETINAL SPECIALIST. NO ONE HAS SAID ANYTHING ABOUT HER LENS AND HAS BEEN UNABLE TO SEE THE LENS. RECENTLY, SHE HAD THE GRANULAR DYSTROPHY REMOVED, BUT EVEN AT POST OP, NO COMMENTS WERE MADE ABOUT HER IOL THAT SHE STRONGLY FEELS HAS A BROKEN HAPTIC AND IS SUBLUXATE IN THE BAG. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Capsular Bag Tear; Hemorrhage/Blood Loss/Bleeding; Visual Impairment; Vitreous Floaters
MAUDE report 16215446 ↗MalfunctionAug 9, 2022Defective Component; Failure to Eject; Defective Component; Failure to Eject
AN OPHTHALMOLOGIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ENCOUNTERED IOL CANNOT GET OUT OF THE CARTRIDGE, THE IOL IS TOO HARD. THE IOL WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15191887 ↗MalfunctionOct 29, 2021Scratched Material; Scratched Material
A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE IOL WAS INSERTED IN PATIENT¿S EYE AND THEN A SCRATCH WAS NOTICED. THE SURGEON REMOVED THE IOL IMMEDIATELY. THE IMPLANT PROCEDURE WAS COMPLETED WITH ANOTHER IOL. THE SURGEON STATED THAT THE ERROR MIGHT HAVE OCCURRED FROM FACILITY END WHILE INSERTING THE IOL IN THE SHOOTER. THERE WAS NO PATIENT HARM NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12723389 ↗MalfunctionAug 18, 2021Particulates; Particulates
A PHYSICIAN REPORTED IN A FOLLOW UP, THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PIECE OF FOLDABLE ACRYLIC MATERIAL WAS INJECTED ALONG WITH THE IOL, THE FOREIGN MATERIAL WAS REMOVED AT THE SAME SURGICAL TIME OF THE IOL IMPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12338776 ↗MalfunctionApr 26, 2021Scratched Material; Scratched Material
A CUSTOMER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A SCRATCH WAS NOTED ON THE LENS DURING INSERTION. THE LENS WAS REMOVED AND A BACKUP LENS WAS IMPLANTED. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE IOL, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE CARTRIDGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11726933 ↗
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- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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