TECNIS IOL ZCT450 (REF ZCT450U185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474602953), received between Mar 2, 2018 and Dec 7, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Unintended Movement” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT450 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). POST-OP DAY ONE, PATIENT'S VISUAL ACUITY WAS REPORTED AS 20/25+ AND SHE WAS HAPPY. BY 1-WEEK POST-OP, VISUAL ACUITY WAS 20/40 AND REFRACTS TO -1.0, +2.50. PHYSICIAN ALSO NOTICED, AFTER DILATING THE PATIENT, THE LENS APPEARED TO HAVE MOVED FROM THE ORIGINAL ACCESS OF 109 DEGREES TO 135 DEGREES. THROUGH FOLLOW UP, REALIGNMENT SURGERY WAS PERFORMED (B)(6) 2018. ON POST VISIT, (B)(6) 2018, RESULTS WERE PL +0.50 20/25- AND PATIENT WAS EXTREMELY HAPPY WITH RESULTS. FURTHER INFORMATION STATED PATIENT HAD PUNCTATE EPITHELIAL EROSION (PEE). THIS WAS OBSERVED ON ALL THREE POST-OP VISITS AND PATIENT HAD A PRE-EXISTING DRY EYE CONDITION. THE DRY EYE RESOLVED BETWEEN WEEK 2 AND 3 AFTER DISCONTINUING POST-OP DROPS AND USE OF NON-PRESCRIPTION ARTIFICIAL TEARS (NPAT) EVERY HOUR/TWO AND PM. PATIENT MAY HAVE HAD POSSIBLE SENSITIVITIES TO TOPICAL BETADINE AND PRE-OP DILATION. PATIENT RETURNED TO BASELINE ARTIFICIAL TEARS (AT) MAINTENANCE PROGRAM AND SURFACE BASELINE BY WEEK 3 IN BOTH PRIOR SURGERIES AND EXPECT THE SAME HERE. EXACT SAME SURFACE FINDINGS AFTER FIRST EYE (LEFT). RI

  Patient problems: Dry Eye(s); No Code Available

  MAUDE report 8144729 ↗
• InjuryMar 2, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) ALIGNED AT SURGERY BASED ON OCULAR RESPONSE ANALYSIS/ANALYZER(ORA) BUT ROTATED 6 DEGREES (FROM 174 DEGREES TO 180 DEGREES) 2 WEEKS POST-OP. THE CUSTOMER COMPLAINS OF SOME BLURRINESS AND TOO MUCH RESIDUAL ASTIGMATISM. REALIGNMENT WAS SCHEDULED FOR (B)(6) 2018. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THERE WAS NO INCISION ENLARGEMENT. THE IOL REMAINS IMPLANTED IN THE LEFT EYE. IT IS UNCLEAR IF THE IOL ROTATED DUE TO PATIENT ACTIVITY OR THE IOL ITSELF. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION, INC.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7310641 ↗