TECNIS IOL ZCU300 (REF ZCU300U200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474660151), received between Jan 13, 2021 and May 11, 2024 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2024Break; Break

  IT WAS REPORTED THE ZCU300MODEL INTRAOCULAR LENS (IOL) WAS NOT IMPLANTED, DEFECTIVE. EXTENT OF PATIENT CONTACT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19295447 ↗
• InjuryMay 5, 2021Adverse 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 NEEDING A DIFFERENT STRENGTH. THERE WAS NO INDICATION OF PATIENT INJURY, OR THAT MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 11780587 ↗
• MalfunctionFeb 9, 2021Unstable; Unstable

  A DOCTOR REPORTED THAT A POST-LASIK PATIENT WAS IMPLANTED WITH AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE OF MODEL ZCU300 ON (B)(6) 2020. THAT THE PATIENT IS NOW SHOWING EVEN MORE CYLINDER IN THE SAME AXIS. MAXIMUM PREOP KS (KERATOMETRY) WERE SHOWN BY IOL MASTER 700 TO BE AROUND 2.1 AXIS 155. MANUAL AND TOPOGRAPHER KS SHOWED LESS, AROUND 1D. ORA (OCULAR RESPONSE ANALYZER) SHOWED VARIABLE, BETWEEN 2 AND 2.2, SAME AXIS. IT WAS INDICATED THAT THE PATIENT WANTED GOOD NEAR UNCORRECTED. POST OP REFRACTION HAS CONSISTENTLY BEEN AROUND -2.50 + 2.50 X 155. THE CURRENT LENS POSITION LOOKS TO BE AROUND AXIS 135. THE DOCTOR NOTED THAT HE DID RUN MULTIPLE SCENARIOS ON ASTIGMATISM FIX, AND HE HAS MADE REPEATED POST-OP MEASUREMENTS. THE IOL MASTER NOW SAYS 3.03D OF CYLINDER, AXIS 155. MANUAL AND TOPO ARE NOT DIFFERENT FROM PRE-OP. THAT JUST ROTATING THE LENS TO THE INDICATED AXIS (A SMALL AMOUNT) LEAVES MORE THAN 2D OF CYLINDER IN THE SAME AXIS; HENCE, THE DOCTOR DETERMINED THAT HE NEEDS TO EXCHANGE THE IOL WITH AT LEAST A ZCU450. THE PATIENT WAS SCHEDULED TO COME IN ON (B)(6) 2021. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11303014 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT INDICATING THE INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO RESIDUAL ASTIGMATISM OBSERVED DURING A POST-OP EXAMINATION. THE PATIENT EXPERIENCED BLURRY VISUAL ACUITY (VA). VA PRE-OPERATIVE 20/30, VA POST-OPERATIVE 20/40. REPORTEDLY, THERE WAS NO VITRECTOMY, SUTURES OR INCISION ENLARGEMENT REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 11160087 ↗