SENSAR IOL AR40e (REF AR40E00255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474502215), received between Jun 15, 2018 and May 8, 2026 — classified as 3 injuries, 5 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.

• MalfunctionMay 8, 2026Break

  THE FOLLOWING WAS REPORTED REGARDING THE JOHNSON (JNJ) INTRAOCULAR LENS (IOL). DURING INSERTION IT WAS NOTICED THAT THE TRAILING HAPTIC WAS BENT. FOLLOW-UP WAS PERFORMED TO GET ADDITIONAL DETAILS BUT THE CUSTOMER HAS NOT RESPONDED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25130017 ↗
• MalfunctionJan 20, 2026Material Fragmentation

  IT WAS REPORTED THAT UPON INSERTION OF THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), IT WAS NOTICED THAT THE TRAILING HAPTIC WAS AMPUTATED, WHICH NECESSITATED THE LENS TO BE REMOVED AND REPLACED WITH BACKUP LENS, PROLONGING SURGICAL TIME. THE BACKUP LENS WAS SUCCESSFULLY INSERTED. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116326 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT THE FRONT HAPTIC OF THE NON PRELOADED INTRAOCULAR LENS(IOL) WAS KINKED. THE LENS WAS PARTIALLY INSERTED. THE ISSUE WAS IDENTIFIED DURING IMPLANTATION/APPLICATION. THE BEST CORRECTED VISUAL ACUITY PRE-OP WAS 20/60, AND THE BEST CORRECTED VISUAL ACUITY POST-OP WAS 20/25+2. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT HAD FULLY RECOVERED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070549 ↗
• InjurySep 22, 2021Material Fragmentation; Device Dislodged or Dislocated; Material Fragmentation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD LENS MODEL AR40 IMPLANTED IN THE SULCUS DUE TO ZONULAR INSTABILITY. BECAUSE THE PATIENT HAD PRE-EXISTING ZONULAR INSTABILITY, A 3 PIECE LENS WAS CHOSEN INSTEAD OF A 1 PIECE LENS. THE FOLLOW-UP EXAMINATION REVEALED THAT THE INTRAOCULAR LENS (IOL) WAS DISPLACED. THE LENS WAS EXPLANTED. DURING THE EXPLANT IT WAS FOUND THAT THE HAPTIC OF THE IOL WAS TORN OFF. PATIENT WAS IMPLANTED WITH AN ARTISAN / VERISYSE IOL AS THE REPLACEMENT LENS. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 12517038 ↗
• InjuryAug 5, 2021Break; Break

  CUSTOMER REPORTED THAT THEIR INTRAOCULAR LENS (IOL) BENT DURING THE INTRAOPERATIVE PERIOD CAUSING PAIN TO THE PATIENT. SUSPECT PRODUCT WILL NOT BE AVAILABLE FOR INVESTIGATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Pain

  MAUDE report 12284242 ↗
• MalfunctionOct 10, 2018Separation Problem; Separation Problem

  IT WAS REPORTED THAT AFTER OPENING THE LENS CASE, IT WAS NOTICED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS DETACHING. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7951438 ↗
• InjuryAug 15, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A SENSAR MONOFOCAL INTRAOCULAR LENS (MODEL AR40E, +25.5 DIOPTER) HAD RESIDUE ON IT. DOCTOR REMOVED THE LENS. REPORTEDLY, INCISION WAS ENLARGED AND WAS CLOSED WITH 10-0 VICRYL. PATIENT WAS DOING FINE AT DISCHARGE. THE LENS WAS REPLACED WITH SAME MODEL WITH DIFFERENT SERIAL NUMBER. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THERE WAS NO PATIENT INJURY, NO OTHER SURGICAL OR MEDICAL INTERVENTION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7785638 ↗
• MalfunctionJun 15, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT A CREASE WAS NOTICED ON THE INTRAOCULAR LENS AR40E 25,5 DIOPTER DURING IMPLANTATION. ACCORDING TO THE PHYSICIAN THERE WAS NO DAMAGE TO THE PATIENT. THE LENS WAS CENTERED AND THE CREASE WAS OUT OF THE OPTIC ZONE. THE LENS REMAINS IMPLANTED IN THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7604639 ↗