TECNIS IOL DIU150 (REF DIU150U235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474746619), received between Sep 29, 2022 and Jul 27, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a preloaded monofocal toric intraocular lens (IOL) was implanted in the patient's right eye. Following the procedure, the patient experienced an unexpected postoperative refractive outcome (myopic surprise), and the physician planned to exchange the implanted lens for another IOL of the same model with a different cylinder and power (DIU225, +22.5 D). The preoperative refraction was reported as -0.50 -0.75 × 105, and the postoperative refraction was reported as plano sphere.Additional information subsequently confirmed that an explant procedure was performed. During the lens exchange procedure, significant anterior segment manipulation was required to explant the original lens. An unplanned second incision was created, and the initial incision was sutured. Intraoperative iris prolapse (mechanical complication) occurred and was successfully managed. The replacement IOL was implanted through the second incision without reported issues. Miochol was administered intraoperatively. No capsule tear or other patient injury was reported, and no additional surgical interventions were required. At the time of reporting, the patient was doing well, was satisfied with the o

  Patient problems: Prolapse; Visual Impairment

  MAUDE report 50015302 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT WAS NOTED TO EXPERIENCE A MYOPIC REFRACTIVE SURPRISE FOLLOWING THE IMPLANTATION OF A SINGLE PIECE PRELOADED TORIC INTRAOCULAR LENS (IOL) IN THE RIGHT EYE STARTING AT POM #1. THE VISUAL SYMPTOMS WERE FIRST OBSERVED DURING A POST-OPERATIVE EXAMINATION. THE PATIENT ALSO EXPRESSED DISSATISFACTION WITH THE UNCORRECTED VISION FOLLOWING CATARACT SURGERY. THE MANIFEST REFRACTION (MRX) WAS A -0.75 SPH, WHEREAS THE TARGET WAS -0.25 DIOPTER. THE ORIGINAL LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY AND WAS REPLACED WITH A JOHNSON AND JOHNSON IOL OF THE SAME MODEL WITH A 23.0 DIOPTER. THE PRE-OPERATIVE BSCVA WAS 20/25-2 AND THE POST-OPERATIVE BSCVA WAS 20/20-1. DAILY ACTIVITIES WERE AFFECTED SPECIFICALLY DIFFICULTY DRIVING AND WORKING. NO UNPLANNED SURGICAL INTERVENTIONS SUCH AS, INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED. NO MEDICATION PRESCRIBED THAT WAS OUTSIDE OF THE STANDARD OF CARE AND NO REPORTED SURGICAL DELAYS. DIRECTIONS FOR USE WAS FOLLOWED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 25211613 ↗
• MalfunctionJan 2, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE IN A SECONDARY SURGERY DUE TO "MECHANICAL COMPLICATION". THE ISSUE WAS OBSERVED DURING POST-OPERATIVE EXAMINATION. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (ZCU150 22.5 DIOPTER). NO UNPLANNED VITRECTOMY, INCISION ENLARGEMENT, SUTURES, OR DELAY IN THE PROCEDURE OCCURRED. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23948566 ↗
• InjuryDec 12, 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 LEFT EYE. THE PATIENT REPORTED EXPERIENCING ¿GHOST IMAGE¿. THE IOL WAS EXPLANTED IN A SECONDARY SURGERY. THE LENS WAS REPLACED WITH A JNJ MODEL ZCU150 23.5 DIOPTER TORIC II LENS. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, SUTURES OR MEDICATION OUTSIDE THE STANDARD OF CARE. THE PATIENT OUTCOME WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 23791576 ↗
• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO MECHANICAL ISSUES. THE MECHANICAL ISSUES DESCRIBED AS DIMINISHED VISION AND GLARE, NOT A PRODUCT ISSUE. THIS WAS REPLACED WITH A DIB00 MODEL OF THE SAME DIOPTER POWER AS THE ORIGINAL IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES PERFORMED. THE PATIENT IS FINE POST-EXPLANT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 18406544 ↗
• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TORIC PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO RESIDUAL ASTIGMATISM AND MYOPIA. THERE WAS NO PATIENT INJURY. THE INCISION WAS ENLARGED AND ONE SUTURE WAS PERFORMED. THE REPLACEMENT LENS WAS OF SAME MODEL. THE PATIENT IS DOING FINE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 18399542 ↗
• MalfunctionSep 25, 2023Break; Crack; Mechanical Jam; Break; Crack; Mechanical Jam

  IT WAS REPORTED BY DOCTOR THAT ANOTHER DOCTOR HAD A SIMILAR EXPERIENCE WHERE THE CARTRIDGE WAS SPLINTERED DURING DELIVERY OF THE IOL, BUT BECAUSE THIS DOCTOR HAD SHARED HIS EXPERIENCE FROM LAST WEEK WITH HER, SHE DIDN'T INJECT THE INTRAOCULAR LENS (IOL) INTO THE EYE, AND WHILE THERE WAS INCREASED RESISTANCE WITH THE BACK UP DELIVERY SYSTEM, SHE WAS ABLE TO INJECT THE BACK UP IOL WITHOUT INCIDENT. ADDITIONAL INFORMATION FROM THE DOCTOR WHO OPERATED THIS CASE STATED THAT THE THIS IS THE FIRST TIME THIS HAS HAPPENED TO HER. ON THE SECOND LENS SHE ASKED THE SCRUB TO OVERFILL THE CARTRIDGE WITH PROVISC. THAT LENS WENT IN FINE, BUT IT MIGHT HAVE BEEN FINE EITHER WAY. THIS HAPPENED WITH A EYHANCE TORIC. IT APPEARS EITHER THE LENS WAS STUCK FROM A MANUFACTURING ERROR, OR SOMETHING ELSE. BUT AS THE PLUNGER WAS GOING DOWN THE LENS/CARTRIDGE IT WAS OBVIOUS THE LENS WAS GETTING DAMAGED BY THE PLUNGER AND THEN THE CARTRIDGE CRACKED IN THE MEANTIME. SINCE THE OTHER DOCTOR HAD TOLD HER ABOUT WHAT HAPPENED TO HIM LAST WEEK, SHE QUICKLY REALIZED THE SAME THING WAS HAPPENING AND PULLED IT OUT OF THE EYE BEFORE BEING INJECTED AND NEEDING TO BE CUT. FURTHER FOLLOW UP STATED THAT ONLY THE CARTRIDGE TIP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814778 ↗
• InjuryNov 17, 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 OPERATIVE EYE DUE TO PATIENT COMPLAINED OF BLURRED VISION, ANISOMETROPIA, AND GLARE AT NIGHT. PATIENT ALSO EXPERIENCED DIPLOPIA, THEREFORE, PATIENT WAS UNHAPPY WITH VISION. VISUAL ACUITY PRE-OPERATIVE (OP): 20/30- AND VISUAL ACUITY POST-OP: 20/30-. THERE WAS NO VITRECTOMY OR SUTURES REQUIRED, HOWEVER, THE INCISION WAS ENLARGED. ANOTHER JOHNSON & JOHNSON LENS, SAME MODEL DIU150 21.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THROUGH FOLLOW-UP, IT WAS LEARNED IT WAS THE PATIENT'S RIGHT EYE. THE LENS EXCHANGE WAS SUCCESSFUL AND THE PATIENT IS SATISFIED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 15820504 ↗
• InjurySep 29, 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 A PATIENT'S RIGHT EYE AS THE PATIENT COMPLAINED OF SEEING CRESCENT IN VISION. THE DOCTOR DIAGNOSIS WAS NEGATIVE DYSPHOTOPSIA. IT WAS ALSO INDICATED THAT LRI (LIMBAL RELAXING INCISION) AND REVERSE OPTIC CAPTURE WERE PERFORMED, AND A NON-JOHNSON & JOHNSON LENS WAS USED AS THE REPLACEMENT. NO OTHER SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED. PATIENT OUTCOME WAS REPORTED TO BE EXCELLENT, AND NO INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 15506544 ↗