SENSAR IOL AR40e (REF AR40E00065)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
- 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 05050474514102), received between Jun 25, 2017 and Aug 21, 2026 — classified as 1 injury, 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Device Contamination with Chemical or Other Material1
- Failure to Unfold or Unwrap1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50383130 ↗MalfunctionOct 19, 2018Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
IT WAS REPORTED WHEN INSERTING AR40E, 6.5 DIOPTER INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE, THE LENS DID NOT UNFOLD TO DOCTOR¿S SATISFACTION. THERE WAS NO MEDICAL INTERVENTION AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE BACKUP LENS. THE PATIENT OUTCOME WAS REPORTED AS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7986778 ↗InjuryJun 25, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS INITIALLY REPORTED THAT THE DOCTOR NOTICED A FILM ON THE INTRAOCULAR LENS (IOL) PRIOR TO INSERTION. AS A RESULT OF FOLLOW UP IT WAS LEARNED THAT THE IOL WAS FULLY INSERTED AND WAS REMOVED. THERE WAS NO VITRECTOMY, NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY HOWEVER ONE SUTURE WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS WITH SAME MODEL AND DIOPTER SIZE NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6666077 ↗
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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