ACRYSOF® SA60WF (REF SA60WF.220)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) ASPHERIC IOL, SINGLE-PIECE ACRYLICFOLDABLE POSTERIOR CHAMBER LENS,UV-ABSORBING, 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS. · Class 3 · Implant
Quick summary
This Alcon AcrySof SA60WF intraocular lens is an implant used during cataract surgery. The 25 reports mostly describe scratches, tears, or other damage during insertion, with some reports mentioning visual problems; there were no deaths and 8 injuries. No recalls name this device. Reports fell from 4 in the previous 12 months to 1 in the latest 12 months.
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
- 25
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00380652332705), received between Jun 11, 2021 and May 7, 2026 — classified as 8 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (7 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 Material7
- Adverse Event Without Identified Device or Use Problem6
- Defective Device3
- Appropriate Device Problem Term/Code Not Available1
- Crack1
- Device Contamination with Chemical or Other Material1
- Device Damaged by Another Device1
- Device Dislodged or Dislocated1
Patient problems
- Insufficient Information9
- No Clinical Signs, Symptoms or Conditions7
- Visual Disturbances5
- Visual Impairment4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Eye Injury2
- Blurred Vision1
- Capsular Bag Tear1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2026Material Split, Cut or Torn
A NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD RIFT AFTER INSERTION. THE LENS WAS INSPECTED BEFORE LOADING, AND THE SAME NURSE LOADED IT AS PER USUAL PRACTICE, USING THE SAME VISCOELASTIC AND THE SAME TYPE OF CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS WAS CAREFULLY INSPECTED BEFORE LOADING AND NO TEARS WAS OBSERVED. AFTER THE LENS UNFOLDED IN THE PATIENT EYE A SIGNIFICANT TEAR WAS SEEN. THE TEAR MUST HAVE OCCURRED IN CONNECTION WITH THE LOADING OF THE LENS. DURING LOADING, THE UTMOST CARE WAS TAKEN, THE OPTIC WAS NOT TOUCHED, AND ALL CONTACT WAS MADE ONLY WITH THE HAPTICS. THE COMPANY CARTRIDGE WAS USED.
Patient problems: Insufficient Information
MAUDE report 25112986 ↗MalfunctionApr 21, 2025Scratched Material; Scratched Material
A NURSE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A SCRATCH ON THE OPTICAL PART OF THE LENS WITH NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21875155 ↗MalfunctionFeb 19, 2025Material Twisted/Bent; Material Twisted/Bent
ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT THE LENS NOT WENT INTO THE EYE BECAUSE IT IS STILL INTACT.
Patient problems: Insufficient Information
MAUDE report 21408958 ↗InjuryFeb 13, 2025Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A LARGE SCRATCH ON THE LENS. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE WOUND WAS ENLARGED FOR REMOVAL OF LENS. THERE WERE NO NEGATIVE CONSEQUENCES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.
Patient problems: Eye Injury
MAUDE report 21372709 ↗InjuryFeb 12, 2025Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A LARGE SCRATCH ON THE LENS. THE LENS WAS NOT LEFT IN THE EYE. FOLDING TWEEZERS WERE REMOVED FROM THE SET AND ARE NOW GOING FOR CLEANING AND WILL THEN BE RETURNED TO THE OPERATION ROOM. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE WOUND WAS ENLARGED FOR REMOVAL OF LENS. THERE WERE NO NEGATIVE CONSEQUENCES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.
Patient problems: Eye Injury
MAUDE report 21363754 ↗MalfunctionNov 29, 2023Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PLUNGER OF THE INJECTOR WENT UNDERNEATH THE LENS. THE SURGEON TRIED TO ADVANCE THE PLUNGER EVEN THOUGH THE TIP WAS UNDERNEATH THE LENS AND THE LENS GOT STUCK IN THE INCISION. THE SURGEON DISLODGED THE LENS FROM THE INCISION AND DECIDED TO USE ANOTHER LENS SINCE THE LENS WAS SCRATCHED BY THE PLUNGER TIP.
Patient problems: Insufficient Information
MAUDE report 18225562 ↗MalfunctionOct 13, 2023Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS BODY HAD A CREVICE OR SCRATCH APPROXIMATELY 1-2MM AWAY FROM THE OPTIC-HAPTIC JUNCTION. THE SURGEON DID NOT REMOVE THE IMPLANTED IOL ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Insufficient Information
MAUDE report 17931157 ↗MalfunctionAug 30, 2023Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION A MARK WAS NOTICED ON IOL BODY. THE PROCEDURE COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17650576 ↗MalfunctionAug 14, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE OPHTHALMOLOGIST EXPERIENCED A LOT OF RESISTANCE DURING LENS IMPLANTATION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17540159 ↗MalfunctionJun 12, 2023Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING THE INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS SCRATCHED. HENCE THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. AS PER THE SURGEON'S OPINION, THE LENS WAS SCRATCHED DURING THE FOLDING PROCESS AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17106652 ↗InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SIGNIFICANT GLARE, EYE PAIN, FLICKER, COULD NOT DRIVE SAFELY AT NIGHT AND HAD A CONTACT LENS SENSATION IN LEFT EYE.
Patient problems: Foreign Body Sensation in Eye; Pain; Visual Disturbances; Visual Impairment
MAUDE report 16770502 ↗InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED GLARE PROBLEMS, STARBURST PATTERNS AROUND LIGHTS AT NIGHT, AND GHOSTING, MADE IT HARD TO READ. PATIENT HAVE COMPLAINED TO THE SURGEON'S OFFICE AND REFERRED TO A RETINAL SPECIALIST THAT FOUND NOTHING WRONG WITH RETINA. THE DOCTOR DID SAY HE SAW A REFLECTION IN PATIENT¿S CORNEA WHICH WAS SOMETHING NEW. PATIENT THOUGHT THAT THESE PROBLEMS WERE A DIRECT RESULT OF THE IMPLANT USED. ADDITIONAL INFORMATION WAS REQUESTED, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE FIRST EYE.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 16582182 ↗InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED GLARE PROBLEMS, STARBURST PATTERNS AROUND LIGHTS AT NIGHT, AND GHOSTING, MADE IT HARD TO READ. PATIENT HAVE COMPLAINED TO THE SURGEON'S OFFICE AND REFERRED TO A RETINAL SPECIALIST THAT FOUND NOTHING WRONG WITH RETINA. THE DOCTOR DID SAY HE SAW A REFLECTION IN PATIENT¿S CORNEA WHICH WAS SOMETHING NEW. PATIENT THOUGHT THAT THESE PROBLEMS WERE A DIRECT RESULT OF THE IMPLANT USED. ADDITIONAL INFORMATION WAS REQUESTED, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE SECOND EYE.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 16582176 ↗MalfunctionMar 14, 2023Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED ABOUT A DAMAGED LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16538187 ↗MalfunctionFeb 6, 2023Patient-Device Incompatibility
I HAD CATARACT SURGERY IN BOTH EYES. THE SAME IMPLANT WAS USED IN BOTH EYES. EVERY SINCE, I HAVE HAD NEW GLARE PROBLEMS, STARBURST PATTERNS AROUND LIGHTS AT NIGHT, AND GHOSTING, MAKING IT HARD TO READ. I HAVE COMPLAINED TO THE SURGEON'S OFFICE, ONLY TO BE REFERRED TO A RETINAL SPECIALIST. THAT PROVED TO BE A WASTE OF TIME AS THEY FOUND NOTHING WRONG WITH MY RETINA. THE DOCTOR DID SAY HE SAW A REFLECTION IN MY CORNEA WHICH IS SOMETHING NEW. ALL ATTEMPTS, EVEN LETTERS, HAVE BEEN IGNORED WITH NO CONTACT FROM THE SURGEON. I THINK THESE PROBLEMS ARE A DIRECT RESULT OF THE IMPLANT USED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Halo; Visual Disturbances
MAUDE report 16311961 ↗MalfunctionJan 2, 2023Crack; Crack
A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A LINE WAS ONLY DETECTED UNDER THE MICROSCOPE AFTER THE IMPLANTATION OF IOL. THE IOL WAS NOT EXPLANTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16082388 ↗MalfunctionDec 28, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS WASTED DUE TO DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16059222 ↗InjuryOct 24, 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 COULD NOT SEE FROM FAR. HE CAN SEE IMPRINTS ON A MEDICINE BOTTLE, BUT HE CAN NOT SEE ANYTHING FROM FAR. ADDITIONAL INFORMATION WAS RECEIVED STATING THE CONSUMER HAS HAD BLURRED VISION FOR DISTANCE SINCE HIS SURGERY. HE COULD SEE BETTER AT A DISTANCE BEFORE HAVING THE SURGERY. HE WAS CAN NOT SEE TO DRIVE. THE PATIENT VISION NOT REALLY IMPROVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE LEFT EYE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 15659498 ↗MalfunctionApr 29, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A PHYSICIAN ASSISTANT REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE STRING WAS FOUND ON THE LENS AND WAS REMOVED BY IRRIGATION AND ASPIRATION. THE SURGERY WAS COMPLETED BY USING NEW MEDICAL DEVICE. NO FURTHER INFORMATION AVAILABLE. ADDITIONAL INFORMATION RECEIVED STATED THAT LENS WAS NOT REMOVED AND ALL THE LENSES REMAINED INSIDE THE EYE.
Patient problems: Insufficient Information
MAUDE report 14249861 ↗InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED NEGATIVE DYSPHOTOPSIA AND SEEN SHADOWS. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PROVIDED THAT THERE WAS NO PATIENT HARM AND NO HOSPITALIZATION.
Patient problems: Visual Disturbances
MAUDE report 14196456 ↗MalfunctionApr 5, 2022Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT THE CLINIC SUSPECTS THAT THIS IS ALSO A PIECE OF LENS MATERIAL THAT WAS ATTACHED TO THE OPTICS.
Patient problems: Insufficient Information
MAUDE report 14015710 ↗InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE/ADMINISTRATOR REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A HOLE WAS NOTICED WHEN THE LENS WAS INSERTED INTO THE EYE. THE LENS WAS REMOVED TO COMPLETE VITRECTOMY AND NEW LENS INSERTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear
MAUDE report 12719948 ↗MalfunctionSep 7, 2021Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED VIA A REPLY CARD THAT THE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12433701 ↗MalfunctionJun 23, 2021Defective Device; Defective Device
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE NOTED THAT THE EDGE OF THE IOL APPEARED UNFINISHED WITH EXTRA ACRYLIC ON THE EDGE. HE TRIED TO ASPIRATE IT OFF THINKING AT FIRST IT MIGHT BE SOME OTHER FOREIGN BODY/MATERIAL BUT CONFIRMED THROUGH THIS PROCESS THAT IT WAS PART OF THE IOL. HE DECIDED TO NOT EXPLANT IT. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING NO PATIENT HARM AND NO OTHER INTERVENTION RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12047429 ↗MalfunctionJun 11, 2021Failure to Advance; Failure to Advance
A HEALTH PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE LENS WOULD NOT ADVANCE THROUGH THE WOUND. PATIENT CONTACT WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11986124 ↗
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.