ACRYSOF® SN60WF (REF SN60WF.150)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
- 10
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380655095713), received between Jul 19, 2021 and Aug 22, 2025 — classified as 6 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Break” (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 Problem4
- Break2
- Defective Device1
- Device Dislodged or Dislocated1
- Device Markings/Labelling Problem1
- Failure to Advance1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Visual Disturbances3
- Blurred Vision1
- Halo1
- Insufficient Information1
- Visual Impairment1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2025Break; Break
A NURSE REPORTED THAT DURING SURGERY, THEY NOTICED THAT IDENTIFIED IOL HAPTIC AMPUTATION AFTER IMPLANTATION. THE LENS WAS CUT AND EXPLANTED, AND REPLACED WITH ANOTHER AVAILABLE LENS. PROCEDURE WAS COMPLETED ON THE SAME DAY. NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22873969 ↗MalfunctionJun 24, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON REALIZED THAT THE HAPTIC WAS BROKEN BEFORE LOADING. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22313343 ↗InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED BLURRY DISTANCES VISION. THE VISION WAS NOT SHARP AS BEFORE. THE PATIENT WAS NOT ABLE TO READ WORDS ON TV SCREENS OR PROJECTED SLIDES AND NOT ABLE TO PERCEIVE THE DEPTH OF SCARS ON UNEVEN PAVEMENTS WHILE WALKING. THE PATIENT WAS EXPERIENCING STAR LIKE INSTANCES , (SATURN) ROUNDISH BODIES SURROUNDED BY AN EQUATORIAL RING) , SPIKY BLOBS LIKE SAUCES. THE MEASURED AND RECOVERED VISUAL POWER WAS 10/10 ON LEFT EYE. BUT PATIENT PERCEPTION WAS INDIVIDUAL LETTERS OF ANY SIZE DON¿T APPEAR AS STRAIGHT SEGMENTS, BUT AS TWISTED (ZIGZAG) SEGMENTS. THE PATIENT HAD SHARPNESS ISSUE.
Patient problems: Blurred Vision; Halo; Visual Disturbances
MAUDE report 19219592 ↗InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT THE INTRAOCULAR LENS WAS EXPLANTED AND THE PATIENT WAS LEFT APHAKIC. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 17540185 ↗InjuryJul 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT COULD NOT SEE WELL DUE TO POOR LENS CENTRATION HENCE THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 17332621 ↗MalfunctionJul 12, 2023Scratched Material; Scratched Material
A PHYSICIAN REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION UPON IMPLANTING THE LENS INTO THE POUCH, THERE WERE OBVIOUS SCRATCHES IN THE LOCATION OF THE MIDDLE OPTICAL ZONE. IN ORDER TO ENSURE THE PATIENT¿S POSTOPERATIVE VISION IS NORMAL, THE PHYSICIAN CHANGED TO A NEW LENS. SUBSEQUENT SUCCESSFUL IMPLANTATION INTO THE PATIENT¿S EYES DID NOT HAVE ANY EFFECT ON THE PATIENT¿S HEALTH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17309958 ↗InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED STARBURSTS WHEN DRIVING AT NIGHT AND IS STARTING TO NOTICE IT WHILE DRIVING DURING THE DAY. A YAG WAS PERFORMED IN EACH EYE AND THERE WAS NO IMPROVEMENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE RIGHT EYE.
Patient problems: Visual Disturbances
MAUDE report 15994908 ↗InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED STARBURSTS WHEN DRIVING AT NIGHT AND IS STARTING TO NOTICE IT WHILE DRIVING DURING THE DAY. A YAG WAS PERFORMED IN EACH EYE AND THERE WAS NO IMPROVEMENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE LEFT EYE.
Patient problems: Visual Disturbances
MAUDE report 15994905 ↗InjuryNov 22, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTER, WHO REPORTED THAT THE PATIENT'S LEFT EYE WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12850556 ↗MalfunctionJul 19, 2021Failure to Advance; Defective Device; Failure to Advance; Defective Device
IT WAS REPORTED BY NON-HEALTHCARE PROFESSIONAL, THAT DOCTOR AND STAFF FELT THAT INTRAOCULAR LENS WAS DEFECTIVE AS TEXTURE OF THE IOL FELT STIFF, NOT SOFT AND WOULD NOT DEPLOY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12187835 ↗
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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