SENSAR IOL AAB00 (REF AAB0000140)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SENSAR 1-PC CLEAR MONO 6.0MM 14.0D · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474548541), received between Jan 10, 2019 and Jan 9, 2020 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Contamination1
Patient problems
- No Code Available2
- No Known Impact Or Consequence To Patient1
- Vitrectomy1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2020Contamination; Contamination
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A FIBER LOOKING SUBSTANCE ATTACHED TO THE LENS THAT THE SURGEON COULD NOT REMOVE. THE LENS WAS INSERTED AND IMMEDIATELY REMOVED. ANOTHER LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9571881 ↗InjuryAug 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL), MODEL AAB00, 14.0 DIOPTER WAS EXPLANTED FROM THE PATIENT'S LEFT EYE (OS) IN A SECONDARY SURGICAL PROCEDURE AS THE PATIENT WAS NOT HAPPY WITH NEAR VISION IN THAT EYE. A REPLACEMENT LENS OF THE SAME MODEL, BUT A DIFFERENT DIOPTER (15.5) WAS USED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 8882359 ↗InjuryJan 10, 2019Break; Break
IT WAS REPORTED THAT AN AAB00 14.0 DIOPTER INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED DURING THE SAME SURGICAL PROCEDURE BECAUSE A DEFECT/BREAK IN THE CENTRAL AREA OF THE LENS WAS FOUND AFTER IMPLANTATION. REPORTEDLY, THERE WAS A DELAY OF 20 MINUTES DUE TO THIS. ALSO, A VITRECTOMY AND INCISION ENLARGEMENT (FROM 2.2MM TO 3.0MM) WERE PERFORMED. THE PATIENT SHOWS NO ABNORMALITY AFTER SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available; Vitrectomy
MAUDE report 8238281 ↗
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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