ACRYSOF® ACRYSERT® SN6CWS (REF SN6CWS.280)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) IQ ASPHERIC IOL, SP ACRYLIC FOLDABLELENS, w/AcrySert(R) DELIVERY SYSTEM, UV w/BLUELIGHT FILTER, 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS. · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652249379), received between Jun 15, 2022 and Jun 15, 2022 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Break1
- Device Dislodged or Dislocated1
- Failure to Advance1
Patient problems
- Eye Pain1
- Glaucoma1
- Headache1
- Intraocular Pressure Increased1
- Nausea1
- Vomiting1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 2022Break; Failure to Advance; Device Dislodged or Dislocated; Break; Failure to Advance; Device Dislodged or Dislocated
A HEALTH AUTHORITY REPRESENTATIVE REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, VISCOELASTIC AGENT WAS INJECTED INTO THE INTRAOCULAR LENS EJECTOR, THE VALVE WAS REMOVED, THE INTERNAL INTRAOCULAR LENS WAS PUSHED UP TO THE PREDETERMINED POSITION, THE EJECTOR WAS ALIGNED WITH THE MAIN INCISION, AND THE INTRAOCULAR LENS WAS PUSHED INTO THE EYE. HOWEVER, WHEN THE INTRAOCULAR LENS IS PUSHED UP TO THE PREDETERMINED POSITION OF THE INJECTOR, THE HAPTIC UNDER THE INTRAOCULAR LENS IS NOT FOLDED AS USUAL, BUT THE WHOLE INTRAOCULAR LENS BODY ROTATES 90 DEGREES WITH THIS HAPTIC AS THE FULCRUM, RESULTING IN THE DEVIATION OF THE FINAL CRIMPING DIRECTION OF THE CRYSTAL FROM THE STANDARD CRIMPING DIRECTION BY 90 DEGREES, AND NO HAPTIC IS ROLLED INTO THE INTRAOCULAR LENS BODY. WHEN THE INTRAOCULAR LENS IS PUSHED INTO THE PATIENT'S EYE, THE INTRAOCULAR LENS HAPTIC BREAKS, THE LOWER HAPTIC REMAINS IN THE EJECTOR, THE UPPER BROKEN HAPTIC ENTERS THE EYE WITH THE SUBSTITUTE PRODUCT, AND THE INTRAOCULAR HAPTIC IS TAKEN OUT IMMEDIATELY. IN THE AFTERNOON AFTER OPERATION, THE PATIENT HAD ELEVATED INTRAOCULAR PRESSURE, NAUSEA AND VOMITING, SEVERE EYE PAIN, HEADACHE, DIZZINESS, CORNEAL EDEMA
Patient problems: Eye Pain; Glaucoma; Headache; Intraocular Pressure Increased; Nausea; Vomiting
MAUDE report 14692465 ↗
Other intraocular lens devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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