TECNIS IOL DIU150 (REF DIU150U200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05050474746541), received between Feb 2, 2022 and Aug 21, 2026 — classified as 7 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Blurred Vision; Vitreous Floaters

  MAUDE report 50379772 ↗
• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED DIMINISHED VISION AND GLARE SYMPTOMS FOLLOWING IMPLANTATION OF INTRAOCULAR LENS FOR THE LEFT EYE. THE VISUAL SYMPTOMS WERE FIRST OBSERVED DURING A POST-OPERATIVE EXAMINATION DURING A SITE VISIT. DAILY ACTIVITIES WERE NOT AFFECTED. THE ORIGINAL LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY AND WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL WITH +24.0 DIOPTER. THE PRE-OPERATIVE BSCVA WAS 20/20-1 AND THE POST-OPERATIVE BSCVA WAS 20/20. NO UNPLANNED SURGICAL INTERVENTIONS SUCH AS, INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED. NO MEDICATION WAS PRESCRIBED THAT WAS OUTSIDE OF THE STANDARD OF CARE. DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 25071242 ↗
• InjuryDec 10, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO A MECHANICAL COMPLICATION. THE PATIENT EXPERIENCED A DECREASE IN VISUAL ACUITY. THERE WERE NO COMPLICATIONS SUCH AS A VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES. THE PATIENT¿S OUTCOME WAS DESCRIBED AS ¿GOOD.¿ JOHNSON AND JOHNSON PERFORMED FOLLOW-UP TO GET MORE DETAILS, BUT THE CUSTOMER INDICATED THAT THERE IS NO MORE INFORMATION AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 23774896 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 RIGHT EYE. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY OR SUTURES. AFTER THE IMPLANT, THE PATIENT WAS UNABLE TO WATCH TV, READ WITH READING GLASSES, IS UNABLE TO RECOGNIZE FACES, HAS LIGHT SENSITIVITY, AND IS WEARING GLASSES INDOORS AND OUTDOORS. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT WAS PRESCRIBED LOTEPREDNOL. THE SYMPTOMS ARE REPORTED AS DEBILITATING TO THE PATIENT. AN IOL EXCHANGE HAS BEEN SCHEDULED FOR (B)(6) 2025. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22516232 ↗
• MalfunctionJan 31, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WHEN DEPLOYED WAS SCRATCHED. THIS WAS POST LASIK AND THE PATIENT NEEDED A TORIC LENS. SO AS AN ADDITIONAL LENS OF THE NEEDED POWER WAS NOT AVAILABLE THE SURGEON HAD LEFT THE LENS IN THE SPACER. THE SCRATCHES WERE SIGNIFICANT AND FAIRLY CENTRAL. IT IS POSSIBLE THAT THE SURGEON MAY NEED TO REPLACE THE LENS IN THE NEAR FUTURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285310 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT WHEN A PRELOADED INTRAOCULAR LENS (IOL) WAS DEPLOYED HAD SOME RESISTANCE AND WHEN IT OPENED IN THE EYE THE LENS WAS OBSERVED TO BE TORN. SURGEON WAS AFRAID AS THE LENS WOULD BE SHARP AND CHAFE SO REMOVED IT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285269 ↗
• MalfunctionDec 26, 2024Break; Device Difficult to Setup or Prepare; Mechanical Jam; Break; Device Difficult to Setup or Prepare; Mechanical Jam

  IT WAS REPORTED THAT THE PRELOADED TORIC INTRAOCULAR LENS (IOL) HAPTIC WAS DAMAGED PRIOR TO INSERTION IN THE EYE. THERE WAS NO PATIENT CONTACT. IT WAS NOTED THAT THE IOL GOT STUCK. THE PROCEDURE WAS COMPLETED USING A BACKUP LENS. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020742 ↗
• MalfunctionOct 24, 2024Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED A MONOFOCAL TORIC INTRAOCULAR LENS (IOL) WASTED. THAT THE IOL WAS DEFECTIVE BEFORE THE DOCTOR INSERTED IT, BUT WAS NOT NOTICED UNTIL AFTER IT WAS INSERTED. THE IOL WAS CRACKED AND RESISTANCE UPON ATTEMPTED THE INSERTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20529715 ↗
• MalfunctionJul 2, 2024Break; Break

  IT WAS REPORTED THAT WHEN THE PRELOADED INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S EYE, SURGEON HAD NOTICED A LARGE DEFECT, IN THE LENS. THE ISSUE WAS NOTICED AFTER THE INSERTION OF THE LENS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19662448 ↗
• MalfunctionNov 4, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) HAD A LENS DEFECT IN THE OPTIC. THE IOL WAS INSERTED AND THEN REMOVED. THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. THERE WERE NO OTHER COMPLICATIONS SUCH AS A CAPSULE TEAR, UNPLANNED VITRECTOMY, OR SUTURES. CUSTOMER INDICATED FOR THE CARTRIDGE LUBRICATION THEY USED ALCON BALANCE SALT SOLUTION (BSS) AT ROOM TEMPERATURE AND NO ADDITIVES. CUSTOMER REPORTED THE CERTIFIED OPHTHALMIC ASSISTANT (COA) PERFORMS THE INITIAL MOVEMENT OF THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070423 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DIU150 20.0 DIOPTER INTRAOCULAR LENS (IOL) HAD PATIENT CONTACT AND THE CAPSULE TORE. IOL WAS REMOVED AND A 3-PIECE, ZA9003 19.5 DIOPTER, IOL WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY. DOCTOR FILLED THE BAG WITH VISCOELASTIC AND IMPLANTED THE IOL IN THE STANDARD MANNER. HE DIDN'T IMMEDIATELY NOTICE ANYTHING, HOWEVER, AS HE TOOK A HOOK AND WENT TO ROTATE THE TORIC LENS THE DOCTOR NOTED THAT THERE APPEARED TO BE AN EQUATOR-TO-EQUATOR TEAR DIRECTLY THROUGH THE CENTER OF THE POSTERIOR CAPSULE. WHILE THE DOCTOR CANNOT BE ABSOLUTELY CERTAIN THAT HE FAILED TO ADEQUATELY INFLATE THE BAG AND CAUSED THE TEAR BY DIRECT TRAUMA TO THE CAPSULE, HE IS FAIRLY SURE THAT THIS WASN'T THE CASE. DOCTOR HAS HEARD A FEW REPORTS OF THIS SAME THING OCCURRING WITH DIU LENSES AND WONDERS IF THERE'S AN ISSUE WITH THE LENS ITSELF, PERHAPS A SHARP EDGE THAT IS TRAUMATIZING THE CAPSULE. THE PATIENT IS DOING WELL, WITH A WELL-PLACED 3-PIECE IOL IN THE SULCUS W/ OPTIC CAPTURE. THERE WAS NO VITREOUS LO

  Patient problems: Capsular Bag Tear

  MAUDE report 16143277 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A ¿SMUDGE¿ IN THE CENTRAL VISION WITH THE INTRAOCULAR LENS (IOL). THE SURGEON IS PLANNING TO EXPLANT THE IOL ON (B)(6) 2022 AND IMPLANT ANOTHER JOHNSON & JOHNSON IOL (DIFFERENT MODEL, ZCU). THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE IOL WAS IMPLANTED IN THE RIGHT EYE AND THE "SMUDGE" IS A VISUAL DISTURBANCE THE PATIENT IS EXPERIENCING, LIKE A BLOB OF GREASE. THE LENS LOOKS CLEAR. THERE IS MINIMAL CAPSULAR OPACITY. OPTICAL COHERENCE TOMOGRAPHY (OCT) OF MACULA IS NORMAL. BCCA: -0.25 +0.75 X 95 20/25. THE PATIENT IS UNABLE TO SEE THE TV OR COMPUTER AND IS HAVING DIFFICULTY AT WORK. AN EXPLANT IS PLANNED FOR AUG 22, 2022. THROUGH ADDITIONAL FOLLOW-UP, IT WAS LEARNED ON AUG 25, 2022 THAT THE IOL WAS EXPLANTED ON AUG 22, 2022. THE SURGEON USED A 2.75 MM KERATOME FOR THE EXPLANT SURGERY AND USED A 2.4 MM KERATOME FOR THE FIRST SURGERY. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, ZCU150, DIFFERENT DIOPTER OF +20.5). THE SECOND SURGERY DID HAVE A SLIGHTLY LARGER INCISION. NO OTHER INTERVENTIONS WERE REQUIRED. THERE WERE NO COMPLICATIONS OR INJURY TO THE PATIENT. THE PATIENT IS DOING WELL. THE PATIENT'S UNCORRECTED VISION

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

  MAUDE report 15423125 ↗
• MalfunctionAug 8, 2022Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD TEAR ON ITS HAPTIC. THERE WAS NO PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15189007 ↗
• InjuryFeb 22, 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 SUSPECT IOL NOT GIVING AN ACCURATE ASTIGMATISM CORRECTION. THE LENS WAS REPLACED WITH ANOTHER DIU150, BUT LOWER DIOPTER (20.5) SIZE IOL. THERE WAS NO PATIENT INJURY. PATIENT WELL POST-OP. IT WAS LEARNED THAT THE SUSPECT PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 13579232 ↗
• MalfunctionFeb 2, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE WHEN AFTER THE INSERTION THE SURGEON DISCOVERED THE IOL WAS CRACKED. THE REPLACEMENT LENS IS THE SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13421275 ↗