ACRYSOF® SA60AT (REF SA60AT.180)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
- 10
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652555760), received between Apr 7, 2022 and Sep 23, 2026 — classified as 2 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (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
- Product Quality Problem2
- Scratched Material2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Crack1
- Defective Device1
- Device Contamination with Chemical or Other Material1
- Failure to Unfold or Unwrap1
Patient problems
- Insufficient Information8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Eye Injury1
- Visual Disturbances1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Material Split, Cut or Torn
A health care professional reported that a crack was observed in the intraocular lens (IOL). Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50867846 ↗MalfunctionAug 28, 2026Scratched Material
Patient problems: Insufficient Information
MAUDE report 50497675 ↗MalfunctionJul 13, 2026Product Quality Problem
Patient problems: Insufficient Information
MAUDE report 25795723 ↗MalfunctionJul 2, 2026Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY WHEN FOLDING TO INSERT INTO CARTRIDGE THE HAPTIC BROKE OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25692125 ↗MalfunctionMay 18, 2026Product Quality Problem
A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT STATES THAT THE IOL WAS DISCARDED DIRECTLY ON THE DAY OF SURGERY.
Patient problems: Insufficient Information
MAUDE report 25201248 ↗MalfunctionJan 17, 2025Scratched Material; Scratched Material
A NURSE REPORTED THAT BEFORE THE CATARACT WITH INTRAOCULAR LENS IMPLANTATION SURGERY, SHE NOTICED SMALL SCRATCH ON THE LENS.
Patient problems: Insufficient Information
MAUDE report 21178615 ↗InjuryFeb 8, 2024Crack; Crack
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS CRACKED. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PRIMARY WOUND WAS ENLARGED TO 3MM TO FACILITATE REMOVAL DURING INITIAL PROCEDURE. THE IOL WAS REPLACED WITH SAME DIOPTER AND MODEL COMPANY LENS. THERE WAS NO PATIENT HARM.
Patient problems: Eye Injury
MAUDE report 18667410 ↗MalfunctionMar 1, 2023Failure to Unfold or Unwrap; Defective Device; Failure to Unfold or Unwrap; Defective Device
A NURSE REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE, GREATER THAN USUAL RESISTANCE WAS OBSERVED WHEN LOADING THE LENS INTO THE CARTRIDGE AND WHEN TRYING TO IMPLANT IT. AFTER THE LENS WAS IMPLANTED AND MOISTENED, THE LENS DID NOT UNFOLD. DUE TO THE ABOVE, THE SURGEON DECIDED NOT TO PLACE THIS PIECE OF IMPLANT. PROCEDURE WAS COMPLETED WITH NEW LENS.
Patient problems: Insufficient Information
MAUDE report 16460449 ↗MalfunctionJan 20, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A NURSE REPORTED THAT WHEN LENS WAS INSERTED DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A FIBER/ DEFECT WAS NOTED. THE LENS WAS REMOVED AND REPLACED WITH A NEW ONE DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16213636 ↗InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE,HE EXPERIENCED NEGATIVE DYSPHOTOPSIA, SEEING A SUDDEN DARK LARGE SPOT OR SHADOW, A FLASH OF LIGHT AT TIMES AND FLOATERS. THE PATIENT ALSO STATED THAT HE DID NOT AGREE WITH, BECAUSE THIS VISUALLY DISTURBING IMAGE OR SIGHTING DIDN¿T LOOK SIMILAR TO THE SMALL FLOATERS I ALREADY HAD BEFORE THE SURGERY. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PATIENT NOTICED LATER IN THE WEEK THE VISUAL PHENOMENA IN THE LEFT EYE PERIPHERY. A DARK SHADOW AND THEN AT TIMES HE NOTICED WHAT HE WOULD COMPARE THE PHENOMENA TO, A CONTACT LENS EDGE AND OPTIC IN THE CORNER OF HIS EYE. THERE WAS ALSO THE FEELING OF STITCHES IN THE EYE AREA. LIFTING BOTH EYELIDS OFF THE EYEBALL, THE DARK SHADOW WOULD DISAPPEAR. OR IF HE RAISED HIS HAND TO THE CORNER OF MY EYE LIKE BLINDERS ON A HORSE THE DARK SHADOW WOULD DISAPPEAR. THE PATIENT STILL WEAR THE SPECIAL SHADES OVER HIS OLD GLASSES IN ORDER TO NOT NOTICE THE VISUAL PHENOMENA IN THE PERIPHERY AREA. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PHYSICIAN FURTHER DID EVALUATION LIKE, EYE WAS DILATED AND THE SURGEON USED THE USUAL SLIT LAMP AND THEN A LASER DEVICE TO POSSIBL
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances
MAUDE report 14039744 ↗
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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