ACRYSOF® SN60WF (REF SN60WF.080)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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380655095577), received between Dec 29, 2021 and Apr 14, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED THAT THEY HAVE QUITE A FEW EXPLANTED IOLS TO REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATE THAT THE INTRA OCULAR LENS DECENTERED TEMPORARILY. THE PATIENT ISSUE WAS RESOLVED AND THE VISUAL ACUITY WAS IMPROVED WITH THE REMOVAL OF THE IOL. THE IOL WAS REPLACED WITH ANOTHER LENS. THE PATIENT WAS NOT HOSPITALIZED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14110624 ↗MalfunctionDec 29, 2021Scratched Material; Scratched Material
A NURSE REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION A SCRATCH WAS SEEN ON THE MIDDLE OF THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE LENS WAS NOT EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13109761 ↗
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- 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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