ACRYSOF® SN60WF (REF SN60WF.260)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) IQ ASPHERIC Natural IOL, SINGLE-PIECE ACRYLIC FOLDABLE PCL, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS. · Class 3 · Implant
All models of ACRYSOF (353)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380655093313), received between Apr 12, 2021 and May 14, 2026 — classified as 5 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Material Opacification” (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
- Adverse Event Without Identified Device or Use Problem3
- Appropriate Device Problem Term/Code Not Available2
- Material Opacification2
- Device Contamination with Chemical or Other Material1
- Failure to Advance1
- Failure to Unfold or Unwrap1
- Material Deformation1
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information5
- No Clinical Signs, Symptoms or Conditions5
- Capsular Bag Tear2
- Bacterial Infection1
- Corneal Edema1
- Endophthalmitis1
- Eye Pain1
- Inflammation1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2026Material Deformation
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING PHAKIC INTRAOCULAR LENS (IOL) IMPLANTATION, GLISTENING OF LENS WAS OBSERVED IN THE PATIENT AFTER SURGERY. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; Posterior Capsule Opacification
MAUDE report 25170093 ↗MalfunctionAug 13, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED HAPTIC DEFORMED/ASYMMETRIC WITH NO PATIENT CONTACT. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22795049 ↗InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED POSTERIOR CAPSULE TORN UPON DELIVERY OF LENS. BACK UP LENS WAS USED AS REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: Capsular Bag Tear
MAUDE report 19019251 ↗InjuryJan 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AS ITS ¿HACK¿ JAGGED IN THE PATIENT FIELD OF VIEW. THE IOL WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE REASON WHY THE LENS WAS REMOVED WAS 4 MARK MEASURED ON. SODIUM CHLORIDE DROPS WAS USED AS A MEDICAL INTERVENTION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18473700 ↗MalfunctionAug 11, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION THAT LENS FAILED TO UNFOLD ONCE IT WAS PLACED INTO THE CAPSULE. THE PROCEDURE WAS COMPLETED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17508314 ↗InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD CHRONIC ENDOPHTHALMITIS THAT LED TO EXPLANT THE LENS. THE LENS WAS SENT OUT TO PATHOLOGY AND IT WAS POSITIVE FOR MODERATE GROWTH OF PARVIBACULUM LAVAMENTIVORANS. THE LENS WAS EXPLANTED AND REPLACED WITH OTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AS THE PATIENT HAD VITREOUS INFLAMMATION, EYE PAIN, LIGHT SENSITIVITY, CORNEAL EDEMA, VITRECTOMY WAS PERFORMED.
Patient problems: Bacterial Infection; Corneal Edema; Endophthalmitis; Eye Pain; Inflammation; Visual Disturbances
MAUDE report 17118833 ↗MalfunctionMar 16, 2023Material Opacification; Appropriate Device Problem Term/Code Not Available; Material Opacification; Appropriate Device Problem Term/Code Not Available
A PHYSICIAN REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE LENS SHOWED GLISTENINGS AND SUPERFICIAL DIFFUSE NOTICEABLE CLOUDINESS. THE LENS STILL REMAINS IMPLANTED. THE PATIENT IS SATISFIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO HARM TO THE PATIENT AND INTERVENTION FOR THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16553518 ↗MalfunctionJun 10, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DEBRIS FOUND ON IOL AFTER IMPLANTING. THE DEBRIS WAS REMOVED BY A CYSTOTOME AND THE IOL IS CLEAR AGAIN. THERE WAS A PATIENT CONTACT, HOWEVER NO PATIENT HARM WAS INVOLVED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14652522 ↗MalfunctionJan 17, 2022Failure to Advance; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE SURGEON HAD DIFFICULTY INJECTING THE LENS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT LENS ON THE SAME DAY. PATIENT CONTACT WAS NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13264389 ↗MalfunctionSep 29, 2021Material Opacification; Appropriate Device Problem Term/Code Not Available; Material Opacification; Appropriate Device Problem Term/Code Not Available
A NON-HEALTH CARE PROFESSIONAL REPORTED VIA REPLY CARD THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE, DRY AND CLOUDY AS PER THE SURGEON. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12547803 ↗InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE CAPSULAR BAG RUPTURED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 12302225 ↗MalfunctionApr 12, 2021Scratched Material; Scratched Material
A HEALTH PROFESSIONAL REPORTED THAT AN INTRAOCULAR LENS (IOL) IMPLANT WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 11648512 ↗
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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