ACRYSOF® SA60WF (REF SA60WF.260)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) ASPHERIC IOL, SINGLE-PIECE ACRYLICFOLDABLE POSTERIOR CHAMBER LENS,UV-ABSORBING, 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652332781), received between Oct 20, 2021 and Jan 30, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (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
- Adverse Event Without Identified Device or Use Problem1
- Failure to Unfold or Unwrap1
- Material Twisted/Bent1
- Scratched Material1
Patient problems
- Blurred Vision1
- Eye Injury1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2026Failure to Unfold or Unwrap; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN SURGEON INTENDED TO IMPLANT THE LENS, WHILE GRASPING THE LENS AND PREPARING TO INSERT IT INTO THE CARTRIDGE, SURGEON NOTICED THAT SOMETHING WAS WRONG WITH THE LENS. UPON CLOSER INSPECTION, IT WAS OBSERVED THAT ONE OF THE LENS HAPTICS WAS CAUGHT WITHIN THE OPTICAL PORTION OF THE LENS, CAUSING THE LENS TO TEAR. THE BACKUP LENS WAS USED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24222369 ↗InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS PARTIALLY IN THE EYE AND HAD TO BE REMOVED TO MAKE A LARGER INCISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PATIENT WAS NOT HOSPITALIZED, NO INTERVENTION WAS NEEDED FOR THE EVENT AND THERE WAS NO HARM TO THE PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH A BACK UP LENS OF THE SAME MODEL AND DIOPTER.
Patient problems: Eye Injury
MAUDE report 13391155 ↗InjuryOct 20, 2021Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN IOL IMPLANT PROCEDURE, THE LENS WAS FOUND OUT TO BE SCRATCHED AT THE ANTERIOR SURFACE. THE PATIENT EXPERIENCE GLARE AND BLURRED VISION, THEREFORE THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 12665815 ↗
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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