SENSAR IOL AR40M (REF AR40MN0030)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474501799), received between Aug 20, 2017 and Dec 27, 2023 — classified as 2 injuries, 7 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.

• MalfunctionDec 27, 2023Break; Break

  IT WAS REPORTED THAT THE NON PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED FROM THE PATIENT'S EYE DURING SAME PROCEDURE DUE HAPTIC DID NOT IN REGULAR SHARP. THERE WAS NO MEDICAL AND SURGICAL INTERVENTION NEEDED. LENS WAS REMOVED AND REPLACED WITH ANOTHER J&J LENS SAME MODEL AND DIOPTER. THE PATIENT'S POST-PROCEDURE STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18400141 ↗
• MalfunctionJun 20, 2023Defective Component; Device Dislodged or Dislocated; Defective Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) CAME WITH DIFFERENT HAPTICS; ONE HAPTIC WAS LONGER THAN THE OTHER, AND WHEN IT ENTERED THE LEFT EYE, THE IOL BECAME DECENTERED AND TILTED. THERE WAS NO PATIENT INJURY. NO MEDICAL OR SURGICAL INTERVENTION HAS BEEN PERFORMED AT THIS TIME. AT THE PATIENT'S FIRST POSTOPERATIVE VISIT ON (B)(6) 2023, THE PATIENT WAS EXPERIENCING DOUBLE VISION AND THE IOL WAS DISPLACED. THE NEXT APPOINTMENT WAS SCHEDULED FOR SEVEN DAYS LATER TO CONFIRM THE OUTCOME. THE SURGEON WILL EXPLANT THE LENS AND IMPLANT ANOTHER ONE, BUT NO DATE IS SCHEDULED YET FOR THE PLANNED EXPLANT. THE IOL REMAINS IMPLANTED AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17167415 ↗
• MalfunctionJan 13, 2022Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT A BENT HAPTIC WAS OBSERVED DURING INTRAOCULAR LENS (IOL) IMPLANTATION. ACCOUNT INDICATED THAT THE IOL CONTACTED THE PATIENT'S OPERATIVE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13256459 ↗
• InjuryOct 20, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING IMPLANTATION THE LENS CRACKED. PART OF THE LENS AND THE TRAILING HAPTIC WAS STILL IN THE INJECTOR CLOSE TO THE BEVEL. NO SIGN OF RESISTANCE/ENTRAPMENT WAS SEEN DURING INJECTION. THE LENS WAS FULLY INSERTED, AND THEN REMOVED AND REPLACED DURING THE SAME PROCEDURE. THE PATIENT FULLY RECOVERED AND DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. SUTURES WERE REQUIRED AND MEDICATION WAS PRESCRIBED. MEDICATION AND SUTURES WERE BELIEVED TO BE PART OF THE NORMAL STANDARD OF CARE. THERE WERE NO OTHER SURGICAL INTERVENTIONS OR DELAY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12663291 ↗
• MalfunctionSep 29, 2021Break; Break

  IT WAS REPORTED THAT A AR40M MODEL INTRAOCULAR LENS(IOL) HAD SHEARED HAPTIC. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12551007 ↗
• MalfunctionMar 25, 2021Break; Break

  IT WAS REPORTED THAT THE HAPTIC WAS FAULTY AND LENS WAS REMOVED FROM THE PATIENT'S EYE AND REPLACED. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572113 ↗
• MalfunctionMar 25, 2021Break; Break

  IT WAS REPORTED THAT DURING A SURGERY HAPTIC WAS FAULTY, LENS WAS REMOVED FROM THE PATIENT'S EYE AND REPLACED WITH A NEW LENS. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572097 ↗
• InjuryNov 10, 2020Failure to Unfold or Unwrap; Physical Resistance/Sticking; Failure to Unfold or Unwrap; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE LENS DID NOT UNFOLD AFTER INSERTION INTO THE EYE. THE LENS REMAINED STUCK (HAPTIC STUCK TO OPTIC), AND WAS REMOVED REQUIRING THE INCISION TO BE ENLARGED AND SUTURES. THE PATIENT RECOVERED FULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10818040 ↗
• MalfunctionAug 20, 2017Bent; Bent

  IT WAS REPORTED THAT A HAPTIC WAS BENT ON A SENSAR MONOFOCAL INTRAOCULAR LENS (IOL), MODEL AR40M -3.0 DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6806610 ↗