SENSAR IOL AAB00 (REF AAB0000135)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SENSAR 1-PC CLEAR MONO 6.0MM 13.5D · Class 3 · Implant
All models of SENSAR IOL (112)
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 05050474548534), received between Oct 13, 2020 and May 19, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Capsular Bag Tear1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2023Break; Break
IT WAS REPORTED THE AAB00 MODEL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE DOCTOR NOTICED DEFECT ON LENS AFTER BEING FULLY INSERTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THE IOL WAS REMOVED AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS, WITH 13.5 DIOPTER SIZE. THERE WAS NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY HOWEVER THE INCISION WAS ENLARGED. PATIENT RECEIVED REGULAR POST-OPERATIVE CARE AND CLEAR SHIELD WAS APPLIED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16966843 ↗MalfunctionNov 10, 2022Break; Break
IT WAS REPORTED THAT, DURING THE SURGERY/AFTER IMPLANTATION, THE HAPTIC WAS LOOSE AND THE INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITH THE BACK-UP LENS. THE DEVICE IS NOT RETURNING FOR EVALUATION. NO ADVERSE EVENT AND NO IMPACT TO PATIENT WAS REPORTED. PATIENT IS DOING WELL POST-OPERATION. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15774163 ↗InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD AN HOLE IN THE CAPSULE OF EYE. EVENT WAS OBSERVED WHEN INSERTING INTO THE EYE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Capsular Bag Tear
MAUDE report 10668672 ↗
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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