ACRYSOF® SA60WF (REF SA60WF.110)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
- 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 00380652332484), received between Jan 12, 2022 and Feb 20, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device1
- Device Markings/Labelling Problem1
Patient problems
- Capsular Contracture1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
A OTHER HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION PATIENT'S VISION WAS EXACTLY THE SAME AS BEFORE THE PROCEDURE AND WAS DIAGNOSED WITH POSTERIOR CAPSULAR PHIMOSIS NEEDING A YAG. THE PATIENT VISION WAS NOT EFFECTED. IT LOOKED AS IF THE IMPLANT HAD NO POWER OR IT WAS A POWER NOT EXCEEDING 1D. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PHYSICIAN PLANS TO IMPLANT ANOTHER LENS INTO THE SULCUS.
Patient problems: Capsular Contracture; Visual Disturbances
MAUDE report 16404360 ↗MalfunctionJan 12, 2022Defective Device; Defective Device
AN IOL REPLY CARD WAS RECEIVED WITH THE REPORT OF DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13234664 ↗
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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