AcrySof Toric Aspheric UV Absorbing IOL SA6AT5 (REF SA6AT5.210)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 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652336840), received between Mar 26, 2021 and Sep 29, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material1
- Device Damaged by Another Device1
- Failure to Eject1
Patient problems
- Foreign Body In Patient1
- 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.
MalfunctionSep 29, 2021Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A IOL BECAME STUCK IN THE CARTRIDGE. THERE WAS PATIENT CONTACT WITH THE DEVICE AND THE PROCEDURE WAS COMPLETED THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12548676 ↗MalfunctionMar 26, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS UNIDENTIFIED PLASTIC LIKE MATERIAL BEHIND THE LENS AFTER INSERTION. ADDITIONAL INFORMATION WAS PROVIDED THAT IT APPEARED THERE WAS A FINE THIN BLUE LINE BEHIND THE LENS. THE SURGEON REMOVED THE DEBRIS WITH AN IRRIGATION/ASPIRATION DEVICE. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FACILITY. THIS REPORT IS ASSOCIATED WITH 3 OF 3.
Patient problems: Foreign Body In Patient
MAUDE report 11574639 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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