SENSAR IOL AR40e (REF AR40E00085)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474514126), received between Sep 21, 2021 and Oct 11, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD VISUAL DISTURBANCES IN THEIR RIGHT EYE HENCE DECIDED TO HAVE THE INTRAOCULAR LENS (IOL) EXPLANTED. THE EXPLANTED LENS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL OF +7.5 DIOPTER. PATIENT FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 15584817 ↗
• InjuryJun 21, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS), THERE WAS IMPROVEMENT IN QUALITY OF VISION, HOWEVER THE PATIENT EXPERIENCED BLURRY VISION AND PERIPHERAL VISION TO THE LEFT NOT CLEAR, DAY ONE POST-OPERATIVELY (OP). THE ISSUE BECAME MORE PRONOUNCED AS TIME WENT ON. AT THE ONE MONTH POST-OP VISIT ON (B)(6) 2021, THE PATIENT EXPLAINED IT AS A "BLONDE PIECE OF HAIR" IN THE VISION AND WHEN LOOKING TO THE SIDE SEES A "FLOWERY" TYPE IMAGE. THE PATIENT ALSO COMPLAINED OF GLARE AT NIGHT, PAIN, AND SORENESS THAT COMES AND GOES AND VISION WAS NOT GREAT. THE PATIENT¿S EYE WAS STILL RED, DISTANCE VISION IS GOOD, UP-CLOSE IS BLURRY. VISUAL ACUITY UNCORRECTED WAS 20/30 ¿ ¿OS DOUBLE LOWER THAN OTHER¿; INTRAOCULAR PRESSURE (IOP) 17/15. IT WAS NOTED THAT THERE ARE SOME STREAKS AND SCRATCHES IN THE LENS TEMPORALLY THAT SEEMED TO BE CORRELATING WITH THE PATIENT¿S SYMPTOMS OF GLARE. SUTURES, WHICH WERE PRE-PLANNED, WERE REMOVED. THE PATIENT WAS OFFERED THE OPTION FOR AN IOL EXCHANGE. THE PATIENT WAS USING LUBRICATING EYE DROPS QHS (EVERY NIGHT AT BEDTIME) OS AND WAS PRESCRIBED PF/VIG QID (FOUR TIMES DAILY), WHICH WAS STANDARD OF CARE, AND WAS TOLD TO RETURN TO T

  Patient problems: Blurred Vision; Eye Pain; Insufficient Information; Red Eye(s); Visual Disturbances

  MAUDE report 14763537 ↗
• MalfunctionFeb 28, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED, HOWEVER, WAS REMOVED AS THE SURGEON NOTICED SCRATCH AFTER IMPLANTING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620760 ↗
• MalfunctionSep 22, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT TRAILING HAPTIC OF AN INTRAOCULAR LENS (IOL) WAS NOTICED TO BE BENT WHILE INSERTING THE LENS INTO THE EYE. THE IOL WAS PARTIALLY INSERTED, CUT OUT AND REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. THE PATIENT WAS REPORTED TO BE TOTALLY FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12516303 ↗
• MalfunctionSep 21, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) TRAILING HAPTIC WAS NOTICED TO BE BENT WHILE INSERTING INTO THE EYE. IOL WAS PARTIALLY INSERTED AND REMOVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510918 ↗