TECNIS IOL ZCU150 (REF ZCU150U225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474657847), received between Jun 10, 2020 and Apr 28, 2022 — classified as 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE INTRAOCULAR LENS (IOL) IMPLANTED IN THE RIGHT EYE LAST YEAR. APPROXIMATELY FOUR TO SIX WEEKS AGO, THE PATIENT BEGAN SEEING A PERFECT CIRCLE WITH A PLUS SIGN IN VISION. THE PATIENT DESCRIBED THE ISSUE AS A ¿MAGNIFYING GLASS WITH A PLUS SIGN IN IT.¿ THE PATIENT REPORTED THAT IT MOVES WITH THE EYE WHEN LOOKING IN DIFFERENT DIRECTIONS. IT IS SEEN MORE CLEARLY WITH BRIGHT LIGHT OR IN SUNLIGHT. THE DOCTOR ADVISED THE PATIENT THAT ALL THAT COULD BE SEEN WAS ¿SCAR TISSUE¿ POST CATARACT SURGERY WHICH MIGHT BE CAUSING THE VISUAL ISSUE. THE PATIENT HAD YTTRIUM ALUMINUM GARNET (YAG) LASER SURGERY ON (B)(6) 2022, WHICH THE DOCTOR BELIEVED WOULD RESOLVE THE VISUAL ISSUE, HOWEVER IT DID NOT. THE PATIENT REPORTED THAT THE VISUAL ISSUE DOES NOT SIGNIFICANTLY INTERFERE WITH DAILY ACTIVITIES; IT IS JUST DISTRACTING. THE PATIENT REPORTED NO PRE-EXISTING OCULAR CONDITIONS. THE PATIENT HAS A FOLLOW-UP SCHEDULED WITH THE DOCTOR ON (B)(6) 2022 TO DISCUSS THE ISSUE FURTHER. THE IOL REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances

  MAUDE report 14232702 ↗
• MalfunctionApr 15, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND HAD TO BE REMOVED/REPLACED DUE TO A SCRATCH OBSERVED ON THE LENS. THE REPLACEMENT LENS MODEL/DIOPTER IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14120791 ↗
• InjuryNov 10, 2020Unintended Movement; Appropriate Device Problem Term/Code Not Available; Unintended Movement; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS PLACED 074 AT DEGREES (078 WAS INTENDED) IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). LENS ROTATED TO 085 DEGREES. PATIENT HAD UNCOMPLICATED NUCLEAR SCLEROTIC (NS) CATARACT AND REGULAR CORNEAL ASTIGMATISM. POST-OP RESULTS WERE REPORTED AS: 20/40 CORRECTABLE WITH +0.75 -1.50 X 85. THE PATIENT WAS UNHAPPY 10 DAYS OUT FROM THE PROCEDURE. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS FOUR LINES OF UNCORRECTED VISUAL ACUITY (UCVA) LOST. PATIENT RESULTED IN 20/40 POST-OP CORRECTABLE TO 20/15 +0.75 -1.50 X 074, IT IMPLIES THAT THE REFRACTIVE ERROR WAS DUE TO THE LENS. THE LENS WAS ROTATED ON (B)(6) 2020 ACCORDING TO (B)(6). THERE WAS NO SERIOUS PATIENT INJURY, BUT THE PATIENT WAS UNHAPPY ABOUT THE UNEXPECTED OUTCOME, (LESS THAN EXPECTED UCVA). PATIENT VISION POST ROTATION IS 20/20 UCVA. ACCOUNT IS CONCERNED THAT (B)(6) RECOMMENDED ROTATION OF 90 DEGREES, TO AN AXIS OF 164, WHICH IMPLIES THAT THE ORIGINAL CALCULATIONS FROM THE (B)(6) WERE OFF BY 90 DEGREES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10820533 ↗
• InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REPOSITIONED DUE TO A REFRACTIVE SURPRISE IN THE PATIENT'S LEFT EYE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT EXPERIENCED BLURRED VISION AND THERE WAS A LOSS OF 2 OR MORE LINES BEST SPECTACLE-CORRECTED VISUAL ACUITY (BSCVA). THE ORIGINAL PLANNED AXIS OF THE LENS APPEARED TO HAVE BEEN INCORRECT, THEREFORE, THE LENS WAS REPOSITIONED. THE PATIENT IS DOING WELL AND THE LENS IS IN THE NEW LOCATION. THE PATIENT IS STILL UNHAPPY WITH HIS CURRENT UNCORRECTED VISION. THE LENS REMAINS IMPLANTED AT THIS TIME. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10141346 ↗