SENSAR IOL AR40M (REF AR40MN0080)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · ACRY 13.5mm 6 OPT MOD C PMMA OPTIEDGE · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474501744), received between Jul 7, 2025 and Feb 19, 2026 — classified as 3 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
- Appropriate Device Problem Term/Code Not Available2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL AR40M AT ¿8.0 DIOPTERS, WAS INTENDED FOR USE BY THE SURGEON DURING AN EMERGENCY CASE. HOWEVER, THE ¿8.0 D LENS HAD TO BE REMOVED (¿CUT OUT¿), AND A REPLACEMENT LENS OF THE SAME MODEL AT ¿5.0 DIOPTERS WAS IMPLANTED INSTEAD. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24396909 ↗MalfunctionFeb 19, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL AR40M AT -8.0 DIOPTERS, WAS INTENDED FOR USE BY THE SURGEON DURING AN EMERGENCY CASE. HOWEVER, THE -8.0 D LENS HAD TO BE REMOVED (¿CUT OUT¿), AND A REPLACEMENT LENS OF THE SAME MODEL AT -5.0 DIOPTERS WAS IMPLANTED INSTEAD. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24396751 ↗MalfunctionJul 7, 2025Break; Break
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE DEFECT WAS NOTICED AFTER THE IOL WAS INSERTED INTO THE PATIENT¿S EYE. THE IOL WAS REMOVED AND REPLACED WITH A BACKUP LENS. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY INCISION ENLARGEMENT, OR SUTURES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22426655 ↗
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- 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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