SENSAR IOL AAB00 (REF AAB0000280)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SENSAR 1-PC CLEAR MONO 6.0MM 28.0D · Class 3 · Implant
Data updated Oct 13, 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 05050474548824), received between Feb 26, 2019 and Feb 26, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Activation” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Difficult or Delayed Activation1
- Material Split, Cut or Torn1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2019Difficult or Delayed Activation; Material Split, Cut or Torn; Difficult or Delayed Activation; Material Split, Cut or Torn
IT WAS REPORTED THAT A AAB00 28.0 DIOPTER MONOFOCAL INTRAOCULAR LENS STARTED TO DELIVER INTO THE PATIENTS LEFT EYE BUT WAS DIFFICULT TO PUSH FORWARD TO IMPLANT. UPON DELIVERY THE LENS SLICED IN HALF AND ONE HALF OF THE IOL WAS IN THE PATIENTS EYE THE OTHER HALF IN THE LOADER. THE PART OF THE LENS THAT WAS IN THE EYE WAS IMMEDIATELY REMOVED. A REPLACEMENT LENS WAS IMPLANTED WITHIN THE SAME PROCEDURE WITHOUT FURTHER INCIDENCE. REPORTEDLY THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8372578 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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