SENSAR IOL AR40M (REF AR40MN0100)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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474501720), received between Sep 29, 2020 and Jan 31, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break2
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Fold, Unfold or Collapse1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Eye Injury1
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 31, 2025Break; Difficult to Fold, Unfold or Collapse; Break; Difficult to Fold, Unfold or Collapse
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAPTIC FAILED TO OPEN DURING IMPLANTATION. THROUGH FOLLOW-UP WE LEARNED THAT THE INCIDENT OCCURRED DURING IMPLANTATION. THE LENS WAS IMPLANTED AND REMOVED DURING THE SAME PROCEDURE AND A REPLACEMENT IOL WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21289318 ↗InjuryFeb 7, 2023Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions
MAUDE report 16309901 ↗InjurySep 29, 2020Break; Break
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD BENT HAPTIC HOWEVER IT WAS LEFT IMPLANTED IN THE PATIENT'S RIGHT EYE AS THE SURGEON FELT THAT IT WAS NOT COMPROMISED ENOUGH TO HAVE ANY ADVERSE OUTCOME. BUT AFTER A FEW DAYS THE SUSPECT IOL WAS EXPLANTED AND PER REPRESENTATIVE IT WAS BECAUSE THE IOL PROVED PROBLEMATIC. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 10597967 ↗
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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