TECNIS IOL ZCU150 (REF ZCU150U235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474657861), received between May 25, 2021 and Jan 21, 2026 — classified as 5 injuries, 1 malfunction.

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

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

  IT WAS REPORTED BY THE PATIENT THAT AFTER THE NON-PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE, THE PATIENT HAS BEEN EXPERIENCING SEVERE POSITIVE DYSPHOTOPSIAS, DESCRIBED AS VISUAL DISTURBANCES RESEMBLING FIREWORKS, CHRISTMAS LIGHTS, FERRIS WHEELS, AND MUSHROOM LIGHTS, PARTICULARLY NOTICEABLE AT NIGHT AND AROUND LIGHT SOURCES, PUDDLES, OR SHINY OBJECTS. GLARE AND BLURRY VISION WERE ALSO REPORTED. THESE SYMPTOMS HAVE SIGNIFICANTLY IMPACTED DAILY ACTIVITIES, INCLUDING DRIVING AND NIGHTTIME OUTINGS. THE PATIENT REPORTED BEING UNABLE TO DRIVE AT NIGHT DUE TO POOR VISION. FOLLOW-UP EXAMINATIONS HAVE INDICATED NO ISSUES, AND ATTEMPTS TO ALLEVIATE THE SYMPTOMS USING BLUE LIGHT GLASSES HAVE NOT RESULTED IN IMPROVEMENT. THE PATIENT WAS INFORMED BY THE DOCTOR THAT TIME IS NEEDED FOR NEUROADAPTATION, HOWEVER THE PATIENT DOES NOT SEE ANY VISUAL IMPROVEMENTS AS TIME PASSES. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO CAPTURE THE RIGHT EYE EVENT. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE PATIENT'S LEFT EYE EVENT.

  Patient problems: Blurred Vision; Discomfort; Flashers; Halo; Visual Disturbances

  MAUDE report 24139699 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT A LENS WAS EXPLANTED BECAUSE THE PATIENT EXPERIENCED HALOS AND DIFFICULTY FOCUSING POSTOPERATIVELY. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH THE SAME MODEL, BUT WITH A LOWER ZCU150 22.0 DIOPTER IOL. THE PATIENT WAS UNABLE TO PERFORM ONE OR MORE DAILY ACTIVITIES AFTER THE SURGERY. ADDITIONAL INFORMATION REVEALED THAT THE PATIENT IS DOING WELL. NO INJURY OR INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 22891864 ↗
• InjuryMay 9, 2025Adverse 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 DUE TO MYOPIC SURPRISE DURING POST OP. VISUAL ISSUES WERE FIRST OBSERVED DURING A POST-OPERATIVE EXAM. THE PATIENT HAD EXPERIENCED DIFFICULTY SEEING CLEARLY, WHICH AFFECTED THE ABILITY TO DRIVE, BUT WAS REPORTED TO HAVE FULLY RECOVERED AFTER THE INTERVENTION. THE EXPLANT WAS PERFORMED DURING A SECONDARY SURGERY, AND THERE WAS A DELAY IN THE PROCEDURE OF ONE MONTH. THE DIRECTION FOR USE WAS FOLLOWED, AND THE BEST CORRECTED VISUAL ACUITY POST-OPERATIVE WAS RECORDED AS 20/40. NO INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 21998998 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO NEGATIVE DYSPHOTOPSIA. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE ISSUE WAS NOT DUE TO THE LENS THE SURGEON THOUGHT THAT THE ACRYLIC MATERIAL OF THE LENS COULD HAVE BEEN CAUSING THE ISSUES, SO THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A LENS FROM ANOTHER MANUFACTURER WHICH IS A DIFFERENT MATERIAL (SILICONE). THERE WAS NO USE ERROR. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 21612775 ↗
• MalfunctionFeb 24, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS LOADED PER MANUFACTURERS INSTRUCTIONS. THE SURGEON IMPLANTED THE IOL AND OBSERVED MARKS ACROSS THE OPTICS OF THE LENS. THE SURGEON FELT IT BEST TO REMOVE AND REPLACE THE LENS. THE IOL WAS REMOVED SAFELY. A BACKUP LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED WITHOUT INCIDENT. THERE WAS NO MEDICAL INTERVENTION, NO VITRECTOMY AND NO SUTURES AT CLOSING OF THE INCISION. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16440668 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED FROM THE PATIENT'S OPERATIVE EYE IN A SECONDARY PROCEDURE DUE TO HYPEROPIC POST-OPERATIVE RESULT, AND BLURRY DISTANCE VISION. THE ONSET DATE WAS (B)(6) 2021 DURING THE POST-OPERATIVE VISIT. AN INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. THE REPLACEMENT LENS IS ANOTHER TORIC LENS. VISUAL ACUITY PRE-OPERATIVE WAS 20/20. VISUAL ACUITY POST-OPERATIVE WAS 20/25 -2 BLURRY. MANIFEST REFRACTION (MRX) +0.75 = 20/20. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 11874843 ↗