SENSAR IOL AAB00 (REF AAB0000120)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SENSAR 1-PC CLEAR MONO 6.0MM 12.0D · Class 3 · Implant
All models of SENSAR IOL (112)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474548503), received between Jan 18, 2022 and Jan 18, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 18, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT AFTER AAB00 +12.0 DIOPTER INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S EYE, DOCTOR NOTICED THAT THE TRAILING HAPTIC WAS BROKEN OFF FROM THE MIDDLE PORTION. LENS WAS REMOVED FROM THE SAME INCISION IT WAS INSERTED. THERE WAS NO PATIENT INJURY AND AFTER REMOVAL OF BROKEN LENS, ANOTHER AAB00 +12.0 DIOPTER WAS INSERTED. A DELAY WAS NOTED. THE CASE WAS COMPLETED WITHOUT ANY OTHER COMPLICATIONS. PATIENT FULLY RECOVERED AND DAILY ACTIVITIES NOT SIGNIFICANTLY AFFECTED. IOL NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13286458 ↗
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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