ACRYSOF® SA60AT (REF SA60AT.190)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
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652555784), received between May 13, 2021 and May 29, 2026 — classified as 6 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Break” (4 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 Problem4
- Break4
- Scratched Material3
- Defective Device2
- Material Discolored2
- Material Split, Cut or Torn2
- Failure to Advance1
- Failure to Unfold or Unwrap1
Patient problems
- Insufficient Information8
- No Clinical Signs, Symptoms or Conditions6
- Eye Injury3
- Blurred Vision1
- Toxic Anterior Segment Syndrome (TASS)1
- Uveitis1
- Visual Impairment1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2026Defective Device
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE IOL.
Patient problems: Insufficient Information
MAUDE report 25328619 ↗MalfunctionApr 24, 2026Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE THE PLUNGER WAS FOLDING THE LENS, THE SURGEON NOTICED THAT ONE OF THE DISTAL TIPS WAS BROKEN. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24982557 ↗InjuryApr 4, 2026Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED AN EXPLANTED LENS WITH AN UNSPECIFIED ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24784497 ↗MalfunctionApr 1, 2026Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, MARK NOTICED ON IOL UPON IMPLANTATION. THE LENS REMAINS IMPLANTED AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24751769 ↗MalfunctionFeb 5, 2026Material Twisted/Bent
A -HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE INTRAOCULAR IMPLANTATION SURGERY IT WAS NOTICED THAT HAPTIC WAS BENT. SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 24267881 ↗MalfunctionMay 20, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WOULD NOT OPEN. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22055966 ↗MalfunctionMar 4, 2025Break; Material Opacification; Break; Material Opacification
A HEALTH CARE PROFESSIONAL REPORTED THAT WHILE IMPLANTING THE LENS CLOUDING ON THE INTRAOCULAR LENS AND HAPTIC BROKEN WAS NOTICED. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT AFTER IMPLANTATION OF THE IOL, A CLOUDING APPEARS CENTRALLY IN THE LENS IN THE OPTICAL AXIS IN THE AREA WHERE THE LENS WAS NOT TOUCHED BY EITHER THE SHOOTER OR THE INJECTOR. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS. THE SURGEON WOULD HAVE TO DESCRIBE WHETHER THE PATIENT SUFFERED ANY IMPAIRMENT POST-SURGERY AND BASED ON DIAGNOSES ASSESS THE FINAL COURSE AND IF NOT RESTORED, THE PROGNOSIS. NO UNSCHEDULED MEDICAL TREATMENT WAS CARRIED OUT, ONLY THE TUNNEL HAD TO BE EXPANDED SLIGHTLY DUE TO THE EXPLANTATION. HOSPITALIZATION OF THE PATIENT WAS NOT NECESSARY.
Patient problems: Eye Injury
MAUDE report 21512797 ↗InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH OPTICAL SURPRISE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS 02 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 19760706 ↗MalfunctionApr 9, 2024Material Discolored; Material Discolored
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE OBSERVED A WHITE SPOT ON TWO LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19070130 ↗MalfunctionApr 9, 2024Material Discolored; Material Discolored
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE OBSERVED A WHITE SPOT ON TWO LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19069416 ↗MalfunctionJul 24, 2023Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS OPTIC HAD A FRACTURE THROUGHOUT THE CENTER WHEN INSERTED INTO THE EYE. THE LENS WAS REMOVED AND THE PROCEDURE COMPLETED THE SAME DAY WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17379063 ↗MalfunctionDec 27, 2022Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE OPTIC FOUND TO BE SCRATCHED AFTER IMPLANTATION IN THE EYE. THE SURGEON EXPLANTED THE LENS WITH NEW ONE. THE SURGERY WAS COMPLETED WITHOUT ANY PATIENT ADVERSE EVENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16052673 ↗InjuryOct 28, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
A NURSE REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE HAPTIC BROKE DURING THE IMPLANTATION IN BOTH CASES, THE SURGERY PROLONGED, WIDENED CUT AND PLACED CORNEAL SUTURES, AFTER REPLACING THE INJECTOR, LENSES WERE IMPLANTED WITHOUT PROBLEMS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Eye Injury
MAUDE report 15688636 ↗InjuryOct 28, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
A NURSE REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE HAPTIC BROKE DURING THE IMPLANTATION IN BOTH CASES, THE SURGERY PROLONGED, WIDENED CUT AND PLACED CORNEAL SUTURES, AFTER REPLACING THE INJECTOR, LENSES WERE IMPLANTED WITHOUT PROBLEMS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Eye Injury
MAUDE report 15688634 ↗MalfunctionSep 14, 2022Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL HAD A SCRATCH DIRECTLY IN THE CENTER OF THE LENS. THE SCRATCH WAS OBSERVED AFTER INSERTION WHEN THE LENS UNFOLDED. THE IOL WAS REMOVED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE LENS WAS REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THERE IS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15417828 ↗MalfunctionApr 25, 2022Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED THAT THE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14191636 ↗InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING A CATARACT EXTRACTION PROCEDURE. THE PATIENT PRESENTED POST-OPERATIVELY WITH NO SIGNS OF SYMPTOMS. UPON EXAMINATION OF THE PATIENT, THE SURGEON NOTED 4+ AQUEOUS CELL AND 2+ AQUEOUS FIBRIN. THE PATIENT WAS PRESCRIBED WITH POST-OPERATIVE ANTIBIOTIC AND STEROID EYE DROPS. NO CULTURES WERE PERFORMED. THE PATIENT'S SYMPTOMS HAVE BEEN RESOLVING WITHOUT ANY ADDITIONAL TREATMENT. THIS IS THE FOURTH OF FOUR REPORTS FOR THIS EVENT.
Patient problems: Toxic Anterior Segment Syndrome (TASS); Uveitis
MAUDE report 12763831 ↗InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CUSTOMER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) PATIENT EXPERIENCED BLURRY VISION DUE TO REFRACTIVE MISS AND INCORRECT POWER. THE LENS WAS EXCHANGED WITH A NEW ONE APPROXIMATELY FOUR MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision
MAUDE report 12407871 ↗MalfunctionJul 14, 2021Failure to Advance; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, LENS DIDN'T COME OUT OF THE INJECTOR PROPERLY, GOT CAUGHT IN THE WOUND AND ONLY PARTIALLY ENTERED THE EYE. DUE TO SCANT MASCARA IN THE SURGICAL FIELD THE FIRST ATTEMPT FAILED. SURGEON OPTED TO USE THE BACKUP FOR SAFETY PURPOSES. MASCARA WAS TOUGH TO REMOVE FULLY, IT LOOKED LIKE A SMALL AMOUNT OF RESIDUAL LIKELY LEFT OVER FROM ONE TO SEVERAL DAYS PRIOR. IT WAS REPORTED THAT THE PRIMARY ISSUE WAS A FAULTY INJECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12168151 ↗MalfunctionMay 13, 2021Break; Break
A FACILITY REPRESENTATIVE REPORTED A DEFECTIVE/BROKEN INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 11820595 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.