TECNIS IOL DIU150 (REF DIU150U220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05050474746589), received between Apr 13, 2022 and Jun 30, 2026 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE. THE PATIENT EXPERIENCED MYOPIC SURPRISE. THE IOL WAS EXPLANTED AND REPLACED WITH THE SAME MODEL BUT A DIFFERENT DIOPTER, DIU150 20.0 DIOPTER. FOLLOW-UP WAS PERFORMED BUT NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 25673167 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENSES (IOLS) WERE IMPLANTED IN BOTH EYES, THE PATIENT EXPERIENCED GLARE FROM HEADLIGHTS AND BRIGHT LIGHT DISBURSEMENTS SURROUNDING OBJECTS AT NIGHT AND WHILE DRIVING, ALONG WITH GIANT SIZE LIGHT AREAS BEING EMITTED FROM THE LENS AT NIGHT DIMINISHING THE ABILITY TO PERCEIVE SPEED AND DISTANCE. THE PATIENT ALSO EXPERIENCED PERIPHERAL GLARE FROM OFFICE BACKGROUND LIGHTING AND PERIPHERAL LIGHT FROM THE SUN WHICH CAUSED THE LENS EDGE TO BE NOTICEABLE CAUSING VISION TO HAVE PERIMETER INTERFERENCE FROM THE LENS. ADDITIONALLY, THE PATIENT EXPERIENCED SEEING BRIGHT SPOTS AND HALOS AROUND LIGHTS APPEARING DURING COMPUTER MONITOR USE AND IT WAS NOTED THAT THE LENSES FAIL TO FUNCTION WITH LED COMPUTER MONITOR SPECTRUM. THE PATIENT FURTHER REPORTED THAT THE CENTER PRISM OF BOTH OPTICS IS APPARENT AND INTERFERES WITH VISION WHILE WORKING. THE SYMPTOMS WERE FIRST NOTED IMMEDIATELY AFTER SURGERY, WHICH WAS REPORTED TO THE DOCTOR WITHIN HOURS. THE PATIENT SOUGHT A SECOND AND THIRD CLINICAL OPINION, WHICH INDICATED THAT SURGERY WOULD NOT RESOLVE THE ISSUES. NO INTERVENTIONS WERE INDICATED OR REPORTED. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE

  Patient problems: Halo; Visual Disturbances

  MAUDE report 23589852 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS OF 22 DIOPTER WAS EXPLANTED AND REPLACED WITH SAME MODEL 20.5 DIOPTER LENS IN A SECONDARY SURGICAL PROCEDURE. LENS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 22760126 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT AFTER CATARACT PROCEDURE PATIENT REPORTED THE DAILY ACTIVITIES OF USING CELL PHONE AND DRIVING WERE AFFECTED BECAUSE OF ANISOMETROPIA. THE LENS WAS EXPLANTED IN THE SECONDARY PROCEDURE AND REPLACED WITH A NON JNJ LENS. THE PATIENT IS DOING FINE, THERE WAS NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION REQUIRED. THEY STATED THERE WAS NO CALCULATION ISSUE OR USE ERROR INVOLVED. THE PATIENT FEELS GOOD ON POST-OP WITH THE REPLACED LENS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 21305106 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FULLY INSERTED PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE IN A SECONDARY SURGERY. THE ISSUE WAS FIRST IDENTIFIED DURING THE POST-OPERATIVE EXAM. DIRECTIONS FOR USE WERE FOLLOWED. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIB00 +21.0 DIOPTER). NO UNPLANNED SUTURES, VITRECTOMY, OR INCISION ENLARGEMENT WAS REQUIRED. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 20888585 ↗
• InjuryNov 20, 2024Unstable; Unstable

  IT WAS REPORTED THAT THERE WAS PLAN OF EXPLANT OF PRELOADED INTRAOCULAR LENS (IOL). FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE PATIENT COMPLAINED OF DIPLOPIA AFTER IMPLANTATION OF THE LENS. THE LENS WAS MULTIFACTORIAL. THE AXIS OF LENS WAS OFF BY A FEW DEGREES, LENS TARGET POWER WAS SLIGHTLY OFF TARGET. PATIENT FEELS BETTER WITH EXCHANGE OF LENS. LENS ALIGNMENT WAS OFF DURING THE IMPLANTATION OF THE LENS. THE LENS WAS 20 DEGREES OFF AXIS. THE LENS DID NOT HAVE OTHER ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 20738667 ↗
• MalfunctionJun 10, 2024Difficult to Fold, Unfold or Collapse; Material Split, Cut or Torn; Difficult to Fold, Unfold or Collapse; Material Split, Cut or Torn

  IT WAS REPORTED THAT UPON INJECTING THE PRELOADED INTRAOCULAR LENS (IOL) INTO THE PATIENT'S LEFT EYE IT WAS NOTICED THAT THE HAPTIC HAD NOT FOLDED AND WAS CAUGHT IN THE PLUNGER AS THE LENS WAS STUCK IN THE CARTRIDGE, AND ESSENTIALLY TORE FROM THE OPTIC. THE ISSUE WAS NOTICED WHEN IT HAD UNFOLDED IN THE PATIENT'S EYE. THE LENS WAS REMOVED AND REPLACED WITH A SAME MODEL LENS IN THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THERE WAS NO USE ERROR. THE PATIENT IS FINE, BUT THERE WAS A LITTLE BIT OF EDEMA NOTICED DURING POST-OP VISIT. THERE WAS NO ANY MEDICAL/SURGICAL INTERVENTION REQUIRED TO RESOLVE THE EDEMA. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Corneal Edema

  MAUDE report 19506946 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DIU150 22.0 DIOPTER MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). PATIENT HAD THE IOLS PUT IN BECAUSE OF CATARACT SURGERY AND AN ASTIGMATISM. SHE REPORTS COMPLAINTS OF BLURRINESS THAT MAKES HER SICK TO HER STOMACH BECAUSE SHE CANNOT SEE DISTANCE. PATIENT INFORMED HER DOCTOR WHO SAID TO GIVE IT TIME AND SHE THINKS IT NEEDS TO BE ROTATED. PATIENT STATED INITIALLY SHE WAS SEEING BLUE BUT THAT HAS STOPPED. SHE COULD DRIVE AFTER OD WAS DONE, BUT AFTER THE LEFT EYE WAS DONE HER VISION HAS NOT EVENED OUT ENOUGH TO ALLOW HER TO SEE THE DISTANCE OF STREET SIGNS ETC. THE SURGEON STATED IN FOLLOW-UP THAT THERE WAS NO SWELLING, BUT HAD A LITTLE DIVOT IN HER EYE BUT DID NOT THINK THIS SHOULD IMPACT VISION. DUE TO PATIENT'S POOR VISION, SHE CALLED ANOTHER DOCTOR AND SCHEDULED AN OFFICE VISIT. SHE WAS ABLE TO READ THE ALPHABET SIGN DURING THE EXAM AND WAS TOLD SHE HAD 20/25 VISION. PATIENT WAS TOLD THERE WAS SWELLING, BUT THAT EVERYTHING LOOKS GOOD. PATIENT USES REFRESH WITH THE ANTIBIOTIC DROPS PRESCRIBED BY THE DOCTOR. SHE ALSO HAS DRY EYE, AND USED TO USE XIIDRA (TWICE A DAY), BUT CURRENTLY IS NOT. NO FURTHER INFORMATION IS AVAILAB

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Dry Eye(s); Swelling/ Edema; Visual Disturbances

  MAUDE report 19449439 ↗
• InjuryApr 25, 2024Difficult to Fold, Unfold or Collapse; Ejection Problem; Difficult to Fold, Unfold or Collapse; Ejection Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL), THE TRAILING HAPTIC WAS NOT FOLDED ON TOP OF THE OPTIC. INSTEAD, IT WAS STUCK TO THE PLUNGER ROD AND AS THE SURGEON WAS MANIPULATING THE LENS TO GET IT OFF OF THE INSERTER, THE LEADING HAPTIC TORE A HOLE IN THE CAPSULAR BAG. NO REPORTED VITREOUS CAME FORWARD. THE LENS WAS FULLY INSERTED AND LEFT IN THE CORRECT POSITION IN THE EYE. MIOCHOL-E WAS USED IN SURGERY AND THE PATIENT WAS INSTRUCTED TO LAY FLAT FOR ONE HOUR POST-OPERATIVE. THE PATIENT WAS CHECKED A FEW HOURS LATER AND THE VISUAL ACUITY WAS FINE AND CAPSULAR BAG HOLE REMAINS STABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 19186701 ↗
• MalfunctionAug 15, 2023Difficult to Fold, Unfold or Collapse; Ejection Problem; Difficult to Fold, Unfold or Collapse; Ejection Problem

  IT WAS REPORTED THAT THE TRAILING HAPTIC WAS STUCK IN CARTRIDGE, SO MUCH THAT THE INTRAOCULAR LENS (IOL) HAD TO BE REMOVED FROM HAPTIC. THE IOL WAS CUT AND TAKEN OUT. ANOTHER JOHNSON & JOHNSON LENS OF THE SAME MODEL AND DIOPTER WAS INSERTED WITHOUT DIFFICULTY. THERE WAS A DELAY IN PROCEDURE; HOWEVER, NO MEDICAL INTERVENTION, NO INCISION ENLARGEMENT, NO SUTURES AND NO VITRECTOMY REPORTED. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553655 ↗
• MalfunctionAug 10, 2023Difficult to Fold, Unfold or Collapse; Material Fragmentation; Device Difficult to Setup or Prepare; Difficult to Fold, Unfold or Collapse; Material Fragmentation; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED. IT WAS NOTED THAT THE TRAILING HAPTIC WAS NOT FOLDED AND IT GOT STUCK IN THE CARTRIDGE AND WOULD NOT RELEASE, THEN TRAILING HAPTIC BROKE OFF. THE DOCTOR HAD TO REMOVE IOL FROM THE EYE DURING THE SAME PROCEDURE. THERE WAS NO PATIENT POST-OP INJURY, PATIENT IS FINE. THE SUSPECT PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17499132 ↗
• MalfunctionJan 11, 2023Scratched Material; Scratched Material

  IT WAS REPORTED AFTER THE DIU150 INTRAOCULAR LENS (IOL) WAS IN THE PATIENT'S OPERATIVE EYE, DOCTOR NOTICED THE LENS WAS DAMAGED, IT LOOKED LIKE A SCRATCH THROUGH THE MIDDLE OF THE LENS. THE LENS WAS EXPLANTED AND ANOTHER LENS WAS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16142071 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IOL WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING NEGATIVE DYSPHOTOPSIA. A NON JNJ IOL WAS IMPLANTED. THERE WERE NO INJURIES OR COMPLICATIONS SUCH AS CAPSULE TEAR, INCISION ENLARGEMENT, VITRECTOMY OR SUTURES. REPORTEDLY, THE PATIENT IS DOING WELL POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 15965089 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO EXPERIENCING HALOS AND GLARE. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 14691767 ↗
• MalfunctionApr 13, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTED, NOT USED, AND WASTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER JOHNSON AND JOHNSON IOL (SAME MODEL AND DIOPTER). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14091588 ↗