SENSAR IOL AR40E (REF AR40E00025)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474514065), received between Sep 7, 2018 and Apr 22, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE LEADING HAPTIC OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) KICKED AFTER THE LENS WAS IMPLANTED IN THE ANTERIOR CHAMBER (AC), MOST LIKELY BECAUSE IT CAUGHT THE PLUNGER WHILE IN THE CARTRIDGE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884437 ↗
• MalfunctionNov 22, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN INSERTING A MONOFOCAL INTRAOCULAR LENS (IOL) INTO THE PATIENT'S OPERATIVE EYE, THE SURGEON NOTICED THAT THE TRAILING HAPTIC HAD BROKEN OFF. THE SURGEON REMOVED THE LENS AND REPLACED IT WITH A BACK UP LENS. THERE WAS NO ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18196721 ↗
• MalfunctionJul 18, 2023Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED DURING IMPLANTATION THE NON-PRE-LOADED AR40E MODEL INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE) AND REMOVED DUE TO TORN IOL DURING THE PROCEDURE. IT WAS ALSO MENTIONED ONLY THE CARTRIDGE TIP CONTACT HAD PATIENT CONTACT WITH PATIENT'S OS. THE IOL WAS WASTED BECAUSE THE TECH LOADED THE LENS INTO MACHINE INCORRECTLY. THE INCISION WAS ENLARGED HOWEVER THERE WAS NO PATIENT INJURY, NO SUTURE(S) AND NO VITRECTOMY. THE REPLACEMENT LENS WAS ANOTHER AR40E 4.0 DIOPTER IOL. PATIENT OUTCOME WAS REPORTED AS FULLY RECOVERED. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DESTROYED. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 17347337 ↗
• MalfunctionApr 23, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) TRAILING HAPTIC BROKE DURING INSERTION. THE LENS WAS REMOVED FROM THE PATIENT'S EYE AND ANOTHER LENS INSERTED DURING THE SAME PROCEDURE. THERE WAS PATIENT CONTACT, BUT NO INJURY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720293 ↗
• InjuryMar 27, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER AN AR40E INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S RIGHT (OD) EYE, THE SURGEON OBSERVED A CRACK IN THE IOL. THE LENS WAS REMOVED AND REPLACED WITH AN UNKNOWN BACK UP LENS DURING THE SAME SURGERY. A VITRECTOMY WAS PERFORMED, HOWEVER THERE WAS NO COMPLICATION NOTED. THE REMOVED LENS HAS BEEN DISCARDED, AND THE PATIENT IS REPORTED TO BE DOING FINE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579856 ↗
• MalfunctionSep 9, 2020Break; Failure to Unfold or Unwrap; Failure to Eject; Break; Failure to Unfold or Unwrap; Failure to Eject

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO THE PATIENT¿S RIGHT DUE TO A BENT HAPTIC AND THE LENS WAS NOT UNFOLDING CORRECTLY. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER DURING THE SAME PROCEDURE. IT WAS STATED THAT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY OR SUTURES REQUIRED. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10506055 ↗
• MalfunctionJul 17, 2020Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED, THE HAPTIC FOLDED, HOWEVER, THE LENS WOULD NOT OPEN. THE LENS WAS REMOVED AND REPLACED WITH THE SAME MODEL AND DIOPTER LENS WITHOUT INCIDENT. THROUGH FOLLOW-UP, IT WAS CONFIRMED THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10292335 ↗
• MalfunctionSep 7, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) KINKED DURING INSERTION INTO THE PATIENT'S OPERATIVE EYE. REPORTEDLY, THE IOL WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7854800 ↗