TECNIS IOL DIU150 (REF DIU150U210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05050474746565), received between Oct 5, 2021 and Jun 18, 2026 — classified as 6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED MONOFOCAL TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED AND SUBSEQUENTLY EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO REFRACTIVE SURPRISE. THE LENS WAS REPLACED WITH ANOTHER LENS OF THE SAME MODEL WITH A LOWER DIOPTER (+20.0). THE ISSUE WAS IDENTIFIED DURING A POST-OPERATIVE EXAMINATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 25556181 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING SEVERE BLURRY VISION WITH PRELOADED TORIC MONOFOCAL INTRAOCULAR LENSES (IOLS) IN BOTH EYES, AFFECTING BOTH DISTANCE AND NEAR VISION. THE PATIENT WAS UNABLE TO FUNCTION ADEQUATELY, AND AN IOL EXCHANGE WAS PLANNED. THESE ISSUES WERE IDENTIFIED DURING A POSTOPERATIVE EXAMINATION. NO PATIENT HARM WAS REPORTED. THE PATIENT HAD A HISTORY OF LASIK (LASER-ASSISTED INTRASTROMAL KERATOMILEUSIS) AND SIGNIFICANT SPHERICAL ABERRATIONS IN THE CORNEAS. THROUGH FOLLOW-UP, IT WAS CONFIRMED THAT THE LENSES IN BOTH EYES WERE EXPLANTED. THE REPLACEMENT LENSES FOR BOTH EYES ARE ANOTHER JOHNSON & JOHNSON, BUT DIFFERENT MODELS AND DIOPTERS: ZCU150 +18.5 D FOR THE RIGHT EYE AND ZCU150 +22.0 D FOR THE LEFT EYE. PREOPERATIVE REFRACTION FOR THE RIGHT EYE (OD) WAS -2.75 -0.75 × 152 WITH A BEST SPECTACLE-CORRECTED VISUAL ACUITY (BSCVA) OF 20/15-2, WHILE POSTOPERATIVE REFRACTION WAS PLANO -0.75 × 152 WITH A BSCVA OF 20/20-1, DESCRIBED BY THE PATIENT AS BLURRY AND DOUBLE. FOR THE LEFT EYE (OS), PREOPERATIVE REFRACTION WAS -2.50 -0.25 × 052 WITH A BSCVA OF 20/15-1, WHILE POSTOPERATIVE REFRACTION WAS -1.50 -0.25 × 006 WITH A BSCVA OF 20/40-1. THE INTENDED TARG

  Patient problems: Blurred Vision

  MAUDE report 24370224 ↗
• MalfunctionJun 27, 2025Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT THE PRE-LOADED TORIC INTRAOCULAR LENS (IOL) MECHANISM DELIVERED LENS IN SUCH A WAY AS THERE WAS A INDENTATION DEFECT ON THE IOL OPTIC AND WAS CUT OUT AND REMOVED FROM PATIENTS LEFT EYE. BACK UP LENS WAS IMPLANTED. THERE WAS NO PATIENT INJURY. SURGERY WAS COMPLETED IN SAME PROCEDURE. DEVICE DID NOT WORK AS INTENDED OR DEVICE ISSUE DURING SET-UP/ PREP/ OR HANDLING. BSS WAS USED AS A LUBRICANT. NO DELIVERY ISSUES OR MANIPULATION WAS NOT REQUIRED TO DEPLOY THE DEVICE. ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WAS A CENTRAL DEFECT THAT OCCURRED DURING DELIVERY OF THE PRE-LOADED IOL. IT LOOKED LIKE THE HAPTIC BENT A DIFFERENT WAY, SO WHEN THE PLUNGER WAS PRESSED FORWARD, IT COULD HAVE INDENTED THE LENS. IT¿S HARD TO SAY. THERE IS NO WAY TO SEE AN DEFECTS PRIOR TO IMPLANTATION. LENS OR HAPTIC WERE NOT STUCK IN CARTRIDGE. NO RESISTANCE FELT DURING DELIVERY; HOWEVER, IT WAS FOLDED WRONG. SOMETIMES IT¿S IMPOSSIBLE TO ¿HOLD ON TO THE PRODUCT¿ AS THIS LENS WAS CUT INTO PIECES TO BE REMOVED. THERE WERE NO COMPLICATIONS, AND THE BACK-UP LENS WENT IN BEAUTIFULLY. NO PATIENT INJURY AND ANY OTHER INTERVENTION WAS NOT REQUIRED. THERE WAS NO USE ERROR. THE PRODUCT WAS DES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350264 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL LENS WAS EXPLANTED DUE TO THE PATIENT NOT SEEING AS WELL AS EXPECTED. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER, A J&J IOL. NO ADDITIONAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 21358995 ↗
• InjurySep 4, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PRE-LOADED TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE BACK IN (B)(6) 2024, BUT IT HAS FAILED. BOTH THE SURGEON AND THE PATIENT FEEL THAT PERHAPS THE IOL ITSELF WAS DEFECTIVE FROM THE START. IT WAS STATED THAT WHEN SUSPECT IOL WAS IMPLANTED THE IOL WAS NOTED TO BE SLOW TO OPEN UPON INSERTION. THE HAPTICS WERE STUCK TO OPTIC ALSO, POST-OP WEEK 1, IT WAS NOTED THAT THE PATIENT HAD AN UNEXPLAINED BLURRY VISION. BUT THERE WAS NO PHYSICAL DEFECTS NOTED ON THE IOL, IT WAS WELL CENTERED. NEVERTHELESS, THE PATIENT HAD AN IOL EXCHANGE ABOUT 5 MONS. POST-IMPLANT. THIS WAS REPLACED WITH A DIB00 IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. IT WAS STATED THAT THE REPLACEMENT IOL HELPED ADDRESS THE VISUAL CONCERNS OF THE PATIENT. THERE WAS NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 20141414 ↗
• MalfunctionJun 10, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THE DIU150 MODEL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED. IT WAS OBSERVED THE HAPTIC WAS MISSING/DETACHED AFTER IOL INSERTION. THE IOL WAS REMOVED AND ANOTHER DIU150 21.0 DIOPTER IOL WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19506887 ↗
• MalfunctionMar 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE ACCOUNT REPORTED TORN OPTIC WITH AN INTRAOCULAR LENS (IOL). NO ISSUES WITH DELIVERY, NO ISSUES WITH INSERTION, NO DELAY AND NO SURGICAL AND/OR MEDICAL INTERVENTIONS REPORTED. IT WAS CONFIRMED THAT THE TORN OPTIC ISSUE HAS NOT IMPACTED THE PATIENT¿S VISION AND NO ACTION IS PLANNED. THERE WAS NO PATIENT INJURY. THE LENS REMAINS IMPLANTED AND THE DELIVERY SYSTEM IS NOT AVAILABLE FOR RETURN. IT WAS INITIALLY NOTED THAT VISCOELASTIC INSERTED INTO PORT FOR HYDRATION PRIOR TO DELIVERY. HOWEVER, ADDITIONAL INFORMATION INDICATED THAT THE BALANCED SALT SOLUTION (BSS) WAS USED WHICH WAS INTRODUCED INTO THE CARTRIDGE FROM THE CARTRIDGE CANOPY. ACCORDINGLY, THE DEVICE WAS PREPARED ACCORDING TO THE DIRECTION FOR USE (DFU). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918279 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DIU150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF PATIENT BEING UNHAPPY WITH OUTCOME; RESIDUAL MYOPIA, BLURRY DISTANCE VISION BUT CAN SEE BETTER AT NEAR VISION, AND VERY LIGHT SENSITIVE. THE REPLACEMENT LENS WAS THE SAME MODEL WITH A DIFFERENT DIOPTER SIZE, DIU150 20.5 DIOPTER IOL. THE EXPLANTED IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. PATIENT OUTCOME POST-LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 18135902 ↗
• MalfunctionDec 13, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S OPERATIVE EYE AND THE HAPTIC WAS BROKEN. LENS WAS REMOVED FROM EYE USING MICROSURGICAL TECHNOLOGY (MST) SET AND NEW LENS WAS INSERTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15974488 ↗
• MalfunctionJun 9, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PRELOADED INJECTOR WAS NOT LOADING THE INTRAOCULAR LENS (IOL) PROPERLY AND THE LENS WAS DAMAGED IN THE PROCESS. THERE WAS NO CONTACT WITH THE PATIENT'S RIGHT (OPERATIVE) EYE. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT WITHOUT ANY ISSUES. THE ORIGINAL LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14649797 ↗
• InjuryJan 6, 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 FROM THE PATIENT'S LEFT EYE DUE TO PATIENT BEING UNHAPPY WITH VISION. THE PATIENT HAD A REFRACTIVE MISS. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. A NON-JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 13173916 ↗
• MalfunctionOct 5, 2021Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE TECNIS EYHANCE PRELOADED INTRAOCULAR LENS (IOL) INSERTER SYSTEM SEEMED TO CRACK WHEN TURNED AND THE IOL FELT ROCK HARD AND CRACKED EVEN AFTER HYDRATION. THE SURGEON WAS UNABLE TO IMPLANT INTO THE PATIENT'S EYE AND HAD TO USE A COMPETITIVE PRODUCT. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580687 ↗
• MalfunctionOct 5, 2021Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE TECNIS EYHANCE PRELOADED INTRAOCULAR LENS (IOL) INSERTER SYSTEM SEEMED TO CRACK WHEN TURNED AND THE IOL FELT ROCK HARD AND CRACKED EVEN AFTER HYDRATION. THE SURGEON WAS UNABLE TO IMPLANT INTO THE PATIENT'S EYE AND HAD TO USE A COMPETITIVE PRODUCT. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580674 ↗