SENSAR IOL AAB00 (REF AAB0000115)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SENSAR 1-PC CLEAR MONO 6.0MM 11.5D · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474548497), received between May 31, 2018 and Feb 11, 2019 — classified as 1 injury, 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
Patient problems
- Blurred Vision1
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2019Break; Break
IT WAS REPORTED THAT AN AAB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED AND IMMEDIATELY REMOVED DUE TO A DEFECT IN THE LENS. THE IOL WAS REPLACED WITH A SIMILAR LENS OF THE SAME POWER. ADDITIONAL INFORMATION REVEALED THE INITIAL LENS, IMPLANTED INTO THE PATIENTS RIGHT EYE, ONE OF THE FILAMENTS BROKE (HAPTIC). THE LENS WAS REMOVED AND WAS REPLACED WITH THE SAME KIND, SAME POWER OF IOL. THERE WERE NO PATIENT INJURIES AND NO ADDITIONAL INTERVENTION WAS REPORTED. THE PATIENT WAS DOING GREAT POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8329774 ↗InjuryMay 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INTRAOCULAR LENS AAB00 +11.5 DIOPTER WAS IMPLANTED IN THE PATIENT LEFT EYE ON (B)(6) 2017. AT THE ONE (1) WEEK POST-OP VISIT, THE PATIENT WAS COMPLAINING OF BLURRY VISION. REPORTEDLY, THE LENS WAS EXPLANTED ON (B)(6) 2018 AND REPLACED WITH A Z9002 LENS +11.0 DIOPTER. THE INCISION WAS ENLARGED, BUT NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. THE PATIENT WAS REPORTED DOING FINE POST-SURGERY. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Blurred Vision; No Code Available
MAUDE report 7556824 ↗
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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