SENSAR IOL AAB00 (REF AAB0000125)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SENSAR 1-PC CLEAR MONO 6.0MM 12.5D · Class 3 · Implant
All models of SENSAR IOL (112)
Data updated Oct 16, 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 05050474548510), received between Jul 21, 2022 and Mar 10, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination” (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
- Contamination1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL), SCRATCHES WERE NOTICED ON THE SURFACE OF THE LENS. THE IOL WAS REMOVED FROM THE EYE AND REPLACED WITH A LENS OF THE SAME MODEL. THE MATERIAL WAS DISCARDED. NO FURTHER DETAILS WERE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21568535 ↗MalfunctionJul 21, 2022Contamination; Contamination
IT WAS REPORTED THAT THERE WAS A STICKY CONSISTENCY ON THE ANTERIOR PORTION OF THE INTRAOCULAR LENS. THE LENS WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE, HOWEVER, WAS REMOVED FROM THE EYE AND A NEW LENS OF SAME MODEL AND DIOPTER WAS INSERTED. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15080472 ↗
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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