AcrySof Toric Aspheric UV Absorbing IOL SA6AT5 (REF SA6AT5.215)Recalls & reported problems
Alcon Laboratories, Inc. · The AcrySof Aspheric UV Absorbing Toric Posterior Chamber Intraocular Lens (IOL) is a UV Absorbing foldable intraocular lens (IOL) · Class 3 · Implant
All models of AcrySof Toric Aspheric UV Absorbing IOL (56)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652336857), received between Oct 25, 2021 and Sep 16, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (2 reports).
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 Device2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blurred Vision1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2022Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) WARPED AND WOULD NOT SIT FLUSH ON THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15441801 ↗MalfunctionFeb 2, 2022Defective Device; Defective Device
A NURSE REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WAS DAMAGED AFTER INSERTION. IN SURGEONS OPINION THE DAMAGE MAY BE FROM LOADING AND THEY FELT LIKE THIS WAS MOSTLY A MANUFACTURING ISSUE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13424069 ↗InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE IOL WAS EXCHANGED WITH AN ANOTHER IOL, 77 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED, THAT IN THE SURGEON'S OPINION RESIDUAL ASTIGMATISM WAS THE CONTRIBUTORY CAUSE. THERE WAS NO PATIENT HARM.
Patient problems: Blurred Vision
MAUDE report 12688040 ↗
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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