SENSAR IOL AR40e (REF AR40E00265)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · AMO Sensar AR40e Lens · Class 3 · Implant
All models of SENSAR IOL (112)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474514164), received between Aug 15, 2017 and Sep 18, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Reports received per month
Most reported problems
Device problems
- Break3
- Adverse Event Without Identified Device or Use Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Code Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830728 ↗MalfunctionAug 7, 2026Break
It was reported that the back haptic of a non-preloaded monofocal intraocular lens (IOL) was damaged during injection. The specific nature of the haptic damage was not identified. There was patient contact . The complaint device was discarded. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50184318 ↗MalfunctionOct 17, 2024Break; Use of Device Problem; Break; Use of Device Problem
IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS DAMAGED AND HAD A LOADING ISSUE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20477338 ↗InjuryAug 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A SENSAR INTRAOCULAR LENS (IOL), MODEL AR40E 26.5 DIOPTER, WAS EXPLANTED FROM A FEMALE PATIENT'S LEFT EYE ON (B)(6) 2017 DUE TO POOR POST-OPERATIVE REFRACTION. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Code Available
MAUDE report 6793613 ↗
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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