TECNIS IOL ZCU150 (REF ZCU150U245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474657885), received between Jan 27, 2022 and Mar 4, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO REFRACTIVE SURPRISE. FOLLOW-UP WAS PERFORMED REGARDING THIS EVENT BUT NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 21521068 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE PATIENT COMPLAINED OF BLURRED NEAR VISION OS AT POST-OP ON (B)(6) 2024. TARGET REFRACTION WAS -1.50. POST-OP REFRACTION ON (B)(6) 2024 WAS -2.50+0.50X178. THE PATIENT EXPRESSED DESIRE FOR AN IOL EXCHANGE PROCEDURE FOR BETTER NEAR VISION. THE PATIENT ALSO EXPERIENCED GLARE AND NEGATIVE DYSPHOTOPSIA. THE IOL WAS EXPLANTED AND REPLACED WITH ANOTHER JNJ TORIC LENS. THE SERIAL NUMBER IS UNKNOWN. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 18876755 ↗
• InjuryJan 17, 2024Adverse 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, IN A SECONDARY PROCEDURE DUE TO WRONG POWER. IOL WAS REPLACED WITH THE SAME MODEL LENS 1.50 POWER SIZE. THERE IS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 18531794 ↗
• MalfunctionOct 13, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TECNIS TORIC INTRAOCULAR LENS HAPTIC WAS BROKE OFF, PATIENT CONTACT AND NO PATIENT HARM. BACKUP LENS WAS USED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931442 ↗
• InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S OCULAR SINISTER (LEFT EYE) IN A SEPARATE SURGICAL PROCEDURE DUE TO COMPLAINTS OF MYOPIC DRIFT. THE IOL WAS REPLACED WITH A DIFFERENT MODEL IOL WITH A DIFFERENT DIOPTER SIZE, LENS MODEL ZCU225 22.0 DIOPTER. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED OUTSIDE OF THE REGULAR STANDARD OF CARE. PATIENT STATUS POST-LENS EXCHANGE WAS REPORTED AS STILL SOME BLURRINESS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 13370603 ↗