TECNIS IOL ZCT150 (REF ZCT150U195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474552135), received between Feb 28, 2017 and Nov 11, 2020 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 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 EXPLANTED FROM A MALE PATIENT¿S RIGHT EYE DUE TO PATIENT EXPERIENCING ASTHENOPIA. THE INCISION WAS ENLARGED TO 3.0 MM. THERE WAS NO COMPLICATIONS AND NO VITRECTOMY OR SUTURES WERE REQUIRED. A REPLACEMENT LENS, MODEL ZCU, 18.0 DIOPTER WAS USED. IT WAS INDICATED THAT THE EXPLANTED LENS WAS NOT SAVE FOR RETURN. ADDITIONALLY, IT WAS INDICATED THAT AT THIS TIME THE DOCTOR HAS PUT THE PATIENT ON A COURSE OF DROPS BECAUSE THE VISION STILL IS NOT THAT GREAT. THE MEDICATIONS GIVEN TO THE PATIENTS ARE DUREZOL 4TIMES PER DAY (QID) AND MOXIFLOCAIN QID BUT THE DOCTOR SAW THE PATIENT ON (B)(6) 2020 AND THE MEDICATION WAS DECREASED DOWN TO TWICE PER DAY (BID) WITH BOTH DROPS. IT WAS INDICATED THAT THE DOCTOR USUALLY GIVES ALL HIS PATIENTS A TRIMOXI INJECTION SO THEY DO NOT NEED DROPS BUT THE DOCTOR PUT THIS PATIENT ON THESE DROPS AT HIS 1-DAY POST-OP APPOINTMENT. IT WAS INDICATED THAT THE DOCTOR WAS SUPPOSED TO EXCHANGE THE PATIENT¿S OTHER EYE (LEFT EYE) AS WELL BUT THE SURGERY WAS CANCELLED AND IT WAS POSTPONED UNTIL SPRING AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; No Code Available

  MAUDE report 10821305 ↗
• InjuryJun 11, 2019Contamination; Contamination

  IT WAS REPORTED THAT THE INTRAOCULAR LENS HAD A VISUAL OPTIC SMUDGE ON IT, MAYBE A POSSIBLE FINGER PRINT, INDICATED AS A VISUAL ISSUE. THE LENS WAS EXPLANTED. THE LENS WAS REPLACED WITH A MODEL ZCT150, DIOPTER 19.5. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8689419 ↗
• MalfunctionFeb 27, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT A ZCT150 19.5 INTRAOCULAR LENS FOUND WITH A SCRATCH UPON RECEIPT. IT WAS NEVER LOADED IN CARTRIDGE. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8372837 ↗
• InjuryDec 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A ZCT150 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE, THE CAPSULAR BAG AND LENS DROPPED TO THE BOTTOM OF THE EYE. THE PATIENT WAS REFERRED TO A RETINA SPECIALIST, WHO HAD TO FISH OUT THE LENS IN A SECONDARY PROCEDURE, DATE UNKNOWN. THE LENS WAS REPORTEDLY REPLACED WITH A SULCUS LENS. REPORTEDLY, THE PATIENT'S ZONULES WERE WEAK. PATIENT WAS REPORTED TO BE POST VITRECTOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 7123549 ↗
• InjuryNov 13, 2017Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WILL BE A FUTURE INTRAOCULAR LENS EXPLANT. THE REASON FOR THE REPORTED EXPLANT WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7026889 ↗
• InjuryOct 17, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT150 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017 AND ROTATED TO 170 DEGREES FROM THE TARGET DEGREE OF 120, WHICH WAS A DIFFERENCE OF 50 DEGREES. IN ADDITION, THE PATIENT'S POST-OPERATIVE VISUAL ACUITY WAS 20/50 AND SHE COMPLAINED OF BLURRY VISION. THEREFORE, A SECOND SURGERY WAS PERFORMED ON (B)(6) 2017 TO ROTATE THE LENS BACK TO THE 120 DEGREE TARGET. POST-OPERATIVELY, THE LENS STAYED AT 120 DEGREES AND THE PATIENT'S VISUAL ACUITY WAS 20/20. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6956703 ↗
• InjuryJul 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS UNCOMFORTABLE WITH LENS THAT WAS IMPLANTED IN RIGHT EYE FOR NEAR VISION. LENS WAS EXPLANTED AND REPLACED WITH ONE FOR FAR VISION.

  Patient problems: Discomfort; No Code Available

  MAUDE report 6751589 ↗
• InjuryApr 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 19.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED DUE TO RESIDUAL REFRACTIVE ERROR. THE LENS WAS EXPLANTED WITH NO COMPLICATIONS, NO INJURY AND NO ADDITIONAL PROCEDURES. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A HIGHER DIOPTER SIZE. PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6526914 ↗
• InjuryFeb 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A MODEL ZCT150 19.5 DIOPTER LENS WAS EXPLANTED FROM A MALE PATIENT¿S LEFT EYE. THE PATIENT HAD PRIOR SURGERY POST CAPSULAR RUPTURE, POOR VISUAL ACUITY AND A NON AMO SULCUS LENS WAS IMPLANTED. THROUGH FOLLOW UP IT WAS CLARIFIED THAT THE DOCTOR REALIZED THAT THE PATIENT HAD A POSTERIOR CAPSULE TEAR FROM A PRIOR SURGERY; THEREFORE, THE PATIENT WOULD NEED TO HAVE ANOTHER TYPE OF LENS AND NOT THE ZCT150. THE DOCTOR IMPLANTED THE LENS (ZCT150) ON (B)(6) 2017 AND IT WAS EXPLANTED ON (B)(6) 2017. THERE WAS INCISION ENLARGEMENT AND TWO (2) SUTURES WERE PLACED. THE CONTACT CONFIRMED THAT THERE WAS NO VITRECTOMY REQUIRED AND NO PATIENT INJURY. THE CONTACT COULD NOT PROVIDE ANYTHING FURTHER REGARDING THE POOR VISUAL ACUITY THAT WAS INITIALLY REPORTED AND DID NOT KNOW THE PATIENT OUTCOME. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 6363443 ↗