ACRYSOF® SN60WF (REF SN60WF.095)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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380655095607), received between Sep 10, 2025 and Apr 13, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Opacification1
Patient problems
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2026Material Opacification
A CONSUMER REPORTED THAT OVER TIME THE INTRAOCULAR LENS (IOL) IMPLANTED IN HIS RIGHT EYE APPROXIMATELY 15 YEARS AGO, BECAME OCCLUDED, LEADING TO DECREASED VISUAL CLARITY. HIS DOCTOR RECOMMENDED HIM A SURGICAL LENS EXCHANGE. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE PATIENT CONTINUES TO EXPERIENCE BLURRY VISION AND INTRALENTICULAR OPACIFICATION. IN THE SURGEON'S OPINION THE IMPLANTED LENS CONTRIBUTED TO THESE EVENTS. THE LENS REMAINS IMPLANTED.
Patient problems: Blurred Vision
MAUDE report 24858675 ↗MalfunctionSep 10, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON FOUND THE LENS TRAILING HAPTIC WAS TORN WHILE INSERTING THE LENS INTO THE COMPANY CARTRIDGE. THE SURGEON DECIDED NOT TO PROCEED WITH IMPLANTATION OF THE DEFECTIVE LENS AND DID NOT INJECT IT INTO THE PATIENT'S EYE. THE PROCEDURE WAS COMPLETED THE SAME DAY USING A BACKUP LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23016591 ↗
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 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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