TECNIS IOL DIU150 (REF DIU150U225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 05050474746596), received between Oct 6, 2021 and Jul 21, 2026 — classified as 14 injuries, 5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A MYOPIC REFRACTIVE SURPRISE FOLLOWING IMPLANTATION OF A SINGLE-PIECE PRELOADED TORIC INTRAOCULAR LENS (IOL). THE DOCTOR EXPLANTED THE AFFECTED IOL AND REPLACED IT WITH THE SAME MODEL IOL OF LOWER POWER. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 25891940 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED TORIC MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FOR AN INITIALLY UNKNOWN REASON. THE LENS WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN. THE REPLACEMENT IOL WAS A NON¿JOHNSON & JOHNSON LENS. FOLLOW-UP INFORMATION INDICATED THAT THE TORIC IOL IMPLANTED IN THE RIGHT EYE WAS EXPLANTED DUE TO CAPSULAR BAG COMPROMISE, WHICH RESULTED IN INADEQUATE CAPSULAR SUPPORT, LENS DECENTRATION, AND INSTABILITY. THE TORIC IOL WAS REMOVED AND REPLACED WITH A THREE-PIECE IOL PLACED IN THE SULCUS. AN ANTERIOR VITRECTOMY WAS PERFORMED DUE TO THE COMPROMISED CAPSULAR BAG. NO SUTURES OR MEDICATIONS OUTSIDE THE STANDARD POSTOPERATIVE REGIMEN WERE REQUIRED. THE PATIENT WAS ABLE TO PERFORM DAILY ACTIVITIES PRIOR TO SURGERY BUT EXPERIENCED A LOSS OF TWO OR MORE LINES OF BEST SPECTACLE-CORRECTED VISUAL ACUITY (BSCVA). PREOPERATIVE REFRACTION WAS -2.75 +1.25 × 095 WITH BSCVA OF 20/40. POSTOPERATIVE REFRACTION WAS -0.50 +0.75 × 090 WITH BSCVA OF 20/25. THE INTENDED REFRACTIVE TARGET WAS PLANO (0.00 D). THE PATIENT WAS NEITHER OVERCORRECTED NOR UNDERCORRECTED, AND THE RESIDUAL REFRACTIVE ERROR WAS WITHIN THE TYPICAL POSTOPERATIVE RANGE. NO SIGNIFICANT PRE-EXISTING CONDITIONS

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

  MAUDE report 24564881 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  THE DIU150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S EYE. POST-OPERATIVELY, THE PATIENT HAD A REFRACTIVE SURPRISE, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH ANOTHER DIU TORIC IOL. THERE WAS NO PATIENT INJURY DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE PROCEDURE IS UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 24438721 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED THAT A MONOFOCAL TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE DUE TO MYOPIC SURPRISE. THE PATIENT HAS A HISTORY OF LASIK. THE INCISION WAS NOT ENLARGED BUT SUTURE (10-0 NYLON) WAS MADE. A REPLACEMENT LENS OF THE SAME MODEL, BUT LOWER DIOPTER ( 20.0D) WAS USED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 20886976 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. AS THERE WAS A BLURRY LINE IN THE OPERATIVE EYE AND VISUAL DISTURBANCES. THE LENS WAS FULLY INSERTED AND REPLACED WITH A SAME MODEL LENS WITH 22.5 DIOPTER. THE ISSUE WAS NOTICES, DURING POST-OP EXAM FEW SEEKS, AFTER THE SURGERY. THE SYMPTOMS HAD PERSISTED FOR THREE MONTHS. THE PATIENT HAD FULLY RECOVERED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 20687854 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE MONOFOCAL TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO AN UNEXPECTED POST-OP REFRACTION. THE VISION PRE-OP: 20/30 AND THE VISION POST-OP: 20/25. ADDITIONAL INFORMATION SUGGESTS THAT THE LENS WAS REPLACED WITH ANOTHER DIU150 , 21.50D LENS HAVING THE HIGHER DIOPTER IOL. STANDARD MEDICATION WAS GIVEN. NO INJURY OR MEDICAL INTERVENTION IS REQUIRED. THE PATIENT'S STATUS IS UNKNOWN. THE PRODUCT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 19614778 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIB00, 22.5 DIOPTER). DUOVISC WAS USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 19542821 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DIU150 22.5 DIOPTER MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT 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 OS 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 AVAILABLE. T

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

  MAUDE report 19450025 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AFTER THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS), THE PATIENT COMPLAINED OF BLURRED VISION AND HALOS AT ALL DISTANCES. TARGET WAS INTERMEDIATE VISION. THE LAST REFRACTION FOR THE OS WAS -1.75+0.75X020. THE PATIENT DESIRES IOL EXCHANGE FOR BETTER VISION AND LESS HALOS. THE INITIAL CATARACT SURGERY OPERATIVE REPORT WAS RECEIVED. THE DESCRIPTION OF THE PROCEDURE INCLUDES THE SURGEON'S STANDARD PRE-OPERATIVE, INTRA-OPERATIVE, AND POST-OP CATARACT SURGERY STEPS WHICH WERE FOLLOWED WITH NO COMPLICATIONS. NO SECONDARY SURGICAL OR MEDICAL INTERVENTIONS WERE PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE SURGERY IS SCHEDULED FOR (B)(6)2024 AND HAS NOT BEEN PERFORMED YET. IT WAS FURTHER NOTED THAT THE PATIENT COMPLAINS OF HALOS WITH LIGHTS. NO QUALITY ISSUE WITH THE DEVICE WAS NOTED. THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE EXPLANT PROCEDURE WAS PERFORMED ON (B)(6), 2024. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIU225). THE PATIENT WAS DOING WELL AT ONE DAY POST-OPERATIVE VISIT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 19184570 ↗
• MalfunctionMar 8, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR (IOL) WAS SCRATCHED. THE ISSUE WAS IDENTIFIED AFTER THE IMPLANTATION AS THE IOL WAS INSERTED IN THE EYE. IT APPEARS THAT THE LENS CAME OUT SCRATCHED AS THERE WAS NO MANIPULATION OF THE LENS PRIOR.. THE LENS WAS EXPLANTED AND REPLACED WITH A SAME MODEL LENS WITH 22.5 D. THE ISSUE WAS NOT DUE TO USE ERROR. THERE WERE NO MEDICAL/SURGICAL INTERVENTIONS PLANNED FOR FUTURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18867560 ↗
• InjuryMar 5, 2024Unstable; Unstable

  PATIENT REPORTED THAT TORIC INTRAOCULAR LENS WAS IMPLANTED ON (B)(6) 2023 IN HER RIGHT EYE AND THE NEXT DAY SHE WAS UNABLE TO SEE. PATIENT EXPLAINED THAT THERE IS A HUGE HALF- MOON SHADOW FROM THE 12 O'CLOCK UNTIL THE 6:00 O'CLOCK AND THAT SHE SAW FIVE LAYERS STACKED. THESE VISUAL PROBLEMS HAD AFFECTED HER FOR THE LAST YEAR. PATIENT IS DISAPPOINTED, UPSET AND REPORTED THAT SHE HAS BEEN TERMINATED FROM A JOB AS A RESULT OF MAKING MISTAKES DUE TO HER VISUAL ISSUES. FEW MONTHS AGO, EYE DROPS WERE PRESCRIBED TO SHRINK EYE PUPIL BUT HIS FAILED AND MADE HER UNSTABLE, DIZZY, NAUSEOUS. GLASSES WERE ALSO TRIED BUT DID NOT WORK. SHE REPORTED THAT HER SURGEON INSISTS THE LENS IS PROPERLY IMPLANTED BUT THAT SHE HAD GONE TO FOUR (4) OTHER EYE SPECIALISTS AND BEEN TOLD BY 3 OF THEM THAT THE LENS IS OUT OF ALIGNMENT. THE LENS WAS EXPLANTED AND REPLACED WITH A NON JNJ DISTANCE VISION ONLY LENS IN A SECONDARY PROCEDURE.

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

  MAUDE report 18843055 ↗
• MalfunctionMay 25, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE AND DOCTOR NOTICED THAT 2 OF THE 8 TORIC ALIGNMENT MARKERS WERE OFF CENTERED. HE HAD REMOVED OPHTHALMIC VISCOSURGICAL DEVICE (OVD) FROM BEHIND THE LENS, SO IT WAS NOT RESIDUAL OVD OR BUBBLES. FURTHER FOLLOW-UP INFORMATION STATED VISUAL FINDINGS ARE 20/25 VISUAL ACUITY (VA) DISTANCE ONE WEEK POST OP, 20/100 VA NEAR. IOL REMAINS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 14497502 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE AS SHE WAS UNHAPPY WITH THE VISION. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THE DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. ANOTHER COMPETITOR LENS OF SAME DIOPTER WAS USED AS THE REPLACEMENT AND THE PATIENT HAS FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 14493488 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO UNEXPECTED MYOPIC SHIFT BY PREOP FORMULAIC MEASUREMENTS-VISUAL AND REFRACTIVE FLUCTUATION EACH POST-OP VISIT. IT WAS INDICATED THAT THE PATIENT¿S DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THERE WAS A DELAY IN PROCEDURE AND MEDICATION WAS PRESCRIBED. THERE WERE SUTURES WERE USED. THE PATIENT¿S STATUS WAS REPORTED AS TEMPORARILY IMPAIRED. NO FURTHER INFORMATION IS AVAILABLE. VISION PRE-OPERATIVE: 20/40; VISION POST-OPERATIVE: 20/50.

  Patient problems: Visual Impairment

  MAUDE report 14274661 ↗
• MalfunctionApr 3, 2022Break; Mechanical Problem; Failure to Advance; Break; Mechanical Problem; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WOULD NOT ADVANCE AS THE PLUNGER ROD WAS GOING ABOVE THE LENS WHEN ADVANCED AND IT WOULD NOT PUSH THE LENS FORWARD. THE LENS WAS ACTUALLY STUCK, FUSED TO THE BOTTOM OF THE INJECTOR, ALMOST AS IF HIGH TEMPERATURE HAD MELTED THE ACRYLIC MATERIAL ONTO THE CARTRIDGE. THE LENS HAVE TO BE PEELED OFF THE BOTTOM OF THE INJECTOR IN ORDER TO FREE IT FROM ITS ORIGINAL POSITION. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF SAME MODEL AND DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13992692 ↗
• MalfunctionMar 31, 2022Break; Mechanical Problem; Failure to Advance; Break; Mechanical Problem; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WOULD NOT ADVANCE AS THE PLUNGER ROD WAS GOING ABOVE THE LENS WHEN ADVANCED AND IT WOULD NOT PUSH THE LENS FORWARD. THE LENS WAS ACTUALLY STUCK, FUSED TO THE BOTTOM OF THE INJECTOR, ALMOST AS IF HIGH TEMPERATURE HAD MELTED THE ACRYLIC MATERIAL ONTO THE CARTRIDGE. THE LENS HAD TO BE PEELED OFF THE BOTTOM OF THE INJECTOR IN ORDER TO FREE IT FROM ITS ORIGINAL POSITION. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF SAME MODEL AND DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13961830 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS NOT ABLE TO READ ROAD SIGNS, FEELS A FILM ON THE BOTTOM RIGHT SIDE OF HER EYE, BLURRY VISION, AND CAN NOT SEE DISTANCE. WITH INTRAOCULAR LENS (IOL). THROUGH FOLLOW-UP, IT WAS LEARNED THE PATIENT STILL HAS BLURRY ISSUES AND FEELS SOMETHING IN HER EYE LIKE THERE IS A FILM ON THE BOTTOM OF HER RIGHT EYE. THE PATIENT EXPLAINED THAT SHE HAS STOPPED DRIVING, BECAUSE SHE IS UNABLE TO READ THE ROAD SIGNS, SEE ROAD CONSTRUCTION, OR CHANGE LANES VERY WELL. THEREFORE, THE PATIENT DECIDED TO STOP DRIVING SINCE HER VISION HAS GONE DOWNHILL. ON (B)(6) 2022 (2 DAYS POST-OPERATIVE), THE PATIENT WAS ABLE TO SEE THE CLOCK ON HER OVEN 6-8 FEET AWAY AND VISION WAS FINE. HOWEVER, ON (B)(6) 2022, THE PATIENT NOTICED SHE COULD NOT SEE VERY WELL AND HAD TO BE 2 FEET FROM THE OVEN JUST TO READ THE CLOCK ON HER OVEN. IN THE 1 WEEK FOLLOW-UP APPOINTMENT ON (B)(6) 2022, THE SURGEON TOLD HER THE LENS LOOKED FINE, VISUAL ACUITY WAS 20/40, AND EVERYTHING WAS PERFECT. THE PATIENT EXPLAINED HER VISUAL ISSUES, HOWEVER, SHE FEELS HER DOCTOR DISMISSED HER COMPLAINTS AND REFERRED HER TO ANOTHER DOCTOR. THE SURGEON EXPLAINED TO THE PATIENT HOW THE LENS IS DESIGNED, THEREFORE, MAY BE

  Patient problems: Blurred Vision; Foreign Body Sensation in Eye; Swelling/ Edema; Visual Disturbances

  MAUDE report 13961399 ↗
• MalfunctionJan 28, 2022Material Fragmentation; Inaccurate Delivery; Mechanical Jam; Material Fragmentation; Inaccurate Delivery; Mechanical Jam

  IT WAS REPORTED THAT THE PRE-LOADED INTRAOCULAR LENS (IOL) DID NOT DEPLOY CORRECTLY FROM THE CARTRIDGE AS THE IOL STUCK TO THE CARTRIDGE. ACCOUNT PROVIDED THAT THE HAPTIC TORE OFF WHILE TRYING TO PUSH THE LENS THROUGH. FURTHER FOLLOW-UP WITH THE ACCOUNT CONFIRMED THAT THERE WAS NO PATIENT CONTACT AND THE IOL FAILED TO LOAD DURING THE PREPARATION STAGE AS THE INSERTER ROD PASSED OVER THE IOL IN THE CARTRIDGE. A BACK-UP IOL WITH THE SAME MODEL AND DIOPTER SIZE WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13389356 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S LEFT EYE DUE TO PATIENT EXPERIENCING BLURRY VISION AND RESIDUAL ASTIGMATISM. THE PATIENT REPORTED OF SOME DIFFICULTY DRIVING DURING THE DAY AND MODERATE DIFFICULTY DRIVING AT NIGHT. THE PATIENT'S SYMPTOMS WERE FIRST NOTICED ON DAY ONE POST-OPERATION. ANOTHER JOHNSON & JOHNSON LENS (DIB00 MODEL AND HIGHER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WERE NO INTERVENTIONS REQUIRED AND NO PATIENT INJURY WAS REPORTED. ON (B)(6) 2021, THE PATIENT WAS 20/20-2. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12587116 ↗