ACRYSOF® SN60AT (REF SN60AT.205)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) Natural SINGLE-PIECE ACRYLICFOLDABLE IOL, UV WITH BLUE LIGHT FILTER,POSTERIOR CHAMBER LENS (IOL/PC), 13.0mm LENGTH,6.0mm 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 00380650130310), received between Apr 8, 2021 and Jun 10, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Opacification” (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
- Appropriate Device Problem Term/Code Not Available1
- Material Opacification1
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information2
- 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.
MalfunctionJun 10, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A SPLITTING OF THE LENS SURFACE, FROM 2:00 TO 8:00 THERE WAS A BRIGHT LINE IN FRONT OF THE METAL TIP. ACCORDING TO THE SURGEON NEITHER THE CARTRIDGE NOR THE INJECTOR IS THE CAUSE, AS THIS SCRATCH IS LOCATED ON THE FRONT SURFACE OF THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14652857 ↗InjuryApr 8, 2021Material Opacification; Appropriate Device Problem Term/Code Not Available; Material Opacification; Appropriate Device Problem Term/Code Not Available
ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED INDICATED THAT FOLLOWING IMPLANTATION OF THE IOLS, " I SAW EVERYTHING SMALL WITH ONE EYE AND EVERYTHING BIG WITH THE OTHER" THEREFORE, PHOTOREFRACTIVE KERATECTOMY (PRK) WAS PERFORMED. DRY EYES, ARTIFICIAL LIGHT FROM ABOVE AND STRANGE VISION PROBLEMS HAVE BEEN PRESENT SINCE THE PROCEDURE. THIS REPORT IS FOR THE RIGHT EYE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11636243 ↗
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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