SENSAR IOL AR40e (REF AR40E00060)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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474501881), received between Mar 29, 2017 and Mar 9, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Bent” (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
- Adverse Event Without Identified Device or Use Problem1
- Bent1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Capsular Bag Tear1
- 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.
InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL AR40E, WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE. A NON¿JOHNSON & JOHNSON NEEDLE (TSK) WAS USED DURING THE PROCEDURE, AND THE HAPTIC BROKE WHILE BEING SUTURED. THE IOL WAS SUBSEQUENTLY CUT IN HALF AND EXPLANTED DURING THE SAME SURGERY. THE PROCEDURE WAS COMPLETED USING A BACKUP IOL OF THE SAME POWER. INCISION ENLARGEMENT, PLACEMENT OF A SUTURE, A VITRECTOMY, AND AN APPROXIMATE 10-MINUTE SURGICAL DELAY WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT¿S POSTOPERATIVE STATUS REMAINED STABLE. THE COMPLAINT DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear
MAUDE report 24551565 ↗InjuryMar 29, 2017Bent; Bent
IT WAS REPORTED THAT DURING/AFTER INSERTION OF AN INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, THE HAPTIC WAS NOTICED TO BE BENT AND THE LENS HAD TO BE CUT OUT. REPORTEDLY, AN UNDEFINED MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO AVOID INJURY OR IMPAIRMENT. THE INTERVENTION WAS NOT IDENTIFIED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 6443951 ↗
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- 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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