SENSAR IOL AR40M (REF AR40MN0045)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 05050474514263), received between Oct 9, 2017 and Oct 4, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (2 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
- Scratched Material2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2024Break; Break
IT WAS REPORTED THAT THERE WAS A DEFECTIVE INFERIOR LOOP BROKEN IN THE CARTRIDGE. LENS WAS CUT AND REMOVED DURING SAME PROCEDURE. THERE WAS NO INCISION ENLARGEMENT AND VITRECTOMY WAS NOT REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20376746 ↗MalfunctionApr 11, 2022Scratched Material; Scratched Material
IT WAS REPORTED THAT THE EVENT OF COSMETIC ISSUE WAS OBSERVED WITH THE INTRAOCULAR LENS (IOL). THERE WAS NO INFORMATION ABOUT PATIENT CONTACT. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14077373 ↗MalfunctionOct 9, 2017Scratched Material; Scratched Material
IT WAS REPORTED THAT THERE WAS A SCRATCH ON A AR40M 4.5 DIOPTER INTRAOCULAR LENS (IOL) DURING HANDLING, PRIOR TO LOADING ON (B)(6) 2017. REPORTEDLY, THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 6933528 ↗
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- 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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