SENSAR IOL AR40M (REF AR40MN0040)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474501782), received between Jan 16, 2019 and May 5, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT THE HAPTICS OF TWO NON-PRELOADED MONOFOCAL INTRAOCULAR LENSES (IOLS) WERE DEFECTIVE. THE EXTENT OF PATIENT CONTACT IS UNKNOWN. THE ISSUE NOTED DURING IMPLANTATION / APPLICATION. NO FURTHERED INFORMATION WAS PROVIDED. THE ISSUE REPORTED WITH TWO LENSES. THIS REPORT IS ONE OUT OF TWO. A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25088746 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT THE HAPTICS OF TWO NON-PRELOADED MONOFOCAL INTRAOCULAR LENSES (IOLS) WERE DEFECTIVE. THE EXTENT OF PATIENT CONTACT IS UNKNOWN. THE ISSUE NOTED DURING IMPLANTATION / APPLICATION. NO FURTHERED INFORMATION WAS PROVIDED. THE ISSUE REPORTED WITH TWO LENSES. THIS REPORT IS TWO OUT OF TWO. A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25088743 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) HAD HAPTIC KINKED, WITH THE ISSUE INVOLVING PATIENT CONTACT. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24439003 ↗
• MalfunctionSep 9, 2025Mechanical Jam; Material Split, Cut or Torn; Mechanical Jam; Material Split, Cut or Torn

  THE AR40M MODEL INTRAOCULAR LENS (IOL) WAS STUCK IN THE LOADER AND THE BACK HALF OF THE IOL TORE IN HALF/WAS MISSING UPON INSERTION; THE IOL WAS FULLY INSERTED. THE IOL WAS REMOVED IMMEDIATELY AND INCISION WAS SLIGHTLY ENLARGED HOWEVER, THERE WAS NO ADVERSE EFFECT ON THE PATIENT, NO SUTURES, AND NO VITRECTOMY. THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP AR40M IOL THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT PROGNOSIS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23012154 ↗
• MalfunctionJun 26, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  AFTER THE AR40M MODEL INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE SURGICAL SITE, THE IOL WAS UNABLE TO UNFOLD COMPLETELY. A NEW IMPLANT WAS SUCCESSFULLY LOADED AND INSERTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THE INCISION WAS ENLARGED AND UNPLANNED SUTURES WERE REQUIRED. THERE WAS NO SERIOUS PATIENT INJURY AND NO VITRECTOMY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19620376 ↗
• MalfunctionApr 7, 2024Break; Break

  IT WAS REPORTED WHEN STARTING TO INSERT THE AR40M MODEL INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE, THE LEADING HAPTIC WAS BENT. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057141 ↗
• MalfunctionJul 19, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED FOLLOWING THE EXPLANT FOR A NON-JNJ LENS. DURING THE IMPLANTATION USING THE JAMANE TECHNIQUE, ONE HAPTIC DETACHED FROM THE IOL WHEN IT WAS PULLED THROUGH THE CONJUNCTIVA. DURING THE ATTEMPT OF REMOVING THE IOL, THE OTHER HAPTIC ALSO DETACHED FROM THE IOL. THE IOL AND BOTH HAPTICS WERE EXPLANTED FROM THE EYE AND REPLACED BY THE STANDBY LENS WITHOUT INCIDENT. THERE WAS A DELAY OF 15 MINUTES AND AN UNPLANNED VITRECTOMY WAS PERFORMED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17352290 ↗
• MalfunctionApr 27, 2021Break; Break

  IT WAS REPORTED THAT A MODEL AR40MN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE PATIENT'S OPERATIVE EYE, WHEN THE SURGEON NOTICED A HAPTIC BROKEN. THE IOL WAS REMOVED AND REPLACED WITH A BACK-UP LENS OF THE SAME MODEL AND DIOPTER. THERE WAS NO SURGICAL OR MEDICAL INTERVENTION REQUIRED. THE PATIENT IS REPORTED TO BE DOING OK POST-OP. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734427 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AR40M, 4.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A MYOPIC MISS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES DONE. REPLACEMENT LENS WAS ANOTHER AR40M BUT A 5.0 DIOPTER. IT WAS STATED THAT THE PATIENT WAS FINE POST-EXPLANT. IT WAS FURTHER LEARNT THAT THE SUSPECT LENS WAS USED AS A PIGGYBACK LENS WITH A SYMFONY TORIC. PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/50 AND POST-EXPLANT BCVA WAS 20/40. VISUAL SYMPTOMS WERE NOTED ON (B)(6) 2019. THE TORIC SYMFONY LENS HAD ROTATED, WAS REPOSITIONED AND PATIENT IS NOW HAPPIER. A SEPARATE REPORT WILL BE FILED FOR THE SYMFONY TORIC LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8760627 ↗
• MalfunctionJan 16, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING HANDLING BUT PRIOR TO INSERTION, IT WAS NOTICED THAT THERE WAS DEBRIS ON THE LENS. THERE WAS NO PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE BACK UP LENS. THE PATIENT IS DOING GOOD POST-OPERATIVELY. NO ISSUES. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 8255457 ↗