SENSAR IOL AR40e (REF AR40E00125)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474501959), received between Aug 17, 2018 and Jun 12, 2026 — classified as 4 injuries, 5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Break; Use of Device Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) HAD A LOADING ISSUE AND THE TRAILING HAPTIC BENT. THE LENS WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE. ANOTHER LENS WAS IMPLANTED AS A REPLACEMENT. IT WAS UNKNOWN IF SUTURES WERE REQUIRED. THERE WAS NO HARM TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494183 ↗
• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THAT POST IMPLANTATION OF THE STANDALONE 3 PIECE MONOFOCAL INTRAOCULAR LENS (IOL), THE SURGEON NOTED A CRACK IN THE OPTIC. THE IOL WAS REMOVED AND REPLACED WITH A 12 DIOPTER AR40E MODEL LENS. THERE WAS A MINOR DELAY TO THE SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039913 ↗
• MalfunctionMay 16, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE THREE PIECE STANDALONE MONOFOCAL INTRAOCULAR LENS (IOL), FAILED TO UNFOLD IN THE EYE AND SUBSEQUENTLY, HAD TO BE REMOVED AND REPLACED WITH A BACK UP IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039596 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE. THE REASON FOR EXPLANT WAS NOT SPECIFIED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 16652096 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT AFTER LENS INSERTED INTO PATIENT EYE, THE HAPTIC WAS BROKEN. IOL WAS REMOVED DURING SAME PROCEDURE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815974 ↗
• InjuryApr 4, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear; Eye Injury

  MAUDE report 14005253 ↗
• MalfunctionMar 18, 2022Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN/TORN; THE EXTENT OF PATIENT CONTACT IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13804120 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH BLURRY VISION SECONDARY TO RESIDUAL MYOPIA (-7.00) POST SENSAR AR40E MODEL INTRAOCULAR LENS (IOL) IMPLANTATION. ACCOUNT INDICATED THAT PATIENT WITH 20/20 PRE-OPERATIVE VISUAL ACUITY. THE IOL WAS EXPLANTED AND EXCHANGED IN A SECONDARY PROCEDURE ON (B)(6) 2021. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 13287373 ↗
• InjuryAug 17, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  REPORT RECEIVED THAT AFTER IMPLANTATION OF AN AR40E INTRAOCULAR LENS (IOL) THE SURGEON NOTED FILM/CONDENSATION APPEARANCE ON THE OPTIC OF THE LENS. POSTOPERATIVELY, THE FEMALE PATIENT COMPLAINED OF BLURRED VISION AND APPEARANCE OF THE FILM/CONDENSATION WAS STILL APPARENT. A YAG (YTTRIUM ALUMINUM GARNET) LASER TREATMENT WAS PERFORMED ON (B)(6) 2018 AND APPEARANCE OF OPTIC HAS IMPROVED AND FILM REDUCED. THROUGH FOLLOW UP IT WAS LEARNED THAT SINCE UNDERGOING THE YAG PROCEDURE THE PATIENT HAS NOT CALLED IN WITH ANY COMPLAINTS. IT WAS STATED THAT FILM APPEARANCE WAS NOT PCO (POSTERIOR CAPSULE OPACIFICATION), BUT IT WAS SOMETHING ON THE SURFACE OF THE LENS. ISSUE HAS SIGNIFICANTLY AFFECTED THE ACTIVITIES OF HER DAILY LIFE AS IT APPEARS SHE IS LOOKING THROUGH A DROP OF WATER. PATIENT'S VISUAL ACUITY RESULTS WERE PIN-HOLE OF 20/30 AND POST-OP CORRECTED OF 20/60 -2 AND THERE ARE NO PLANS TO EXPLANT THE LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 7794683 ↗