TECNIS IOL ZCT300 (REF ZCT300U190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474553309), received between Aug 24, 2016 and Jul 24, 2020 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO COMPLAINTS OF BLURRED CROOKED VISUAL ACUITY (VA), AND LINE OF LIGHT AT NIGHT. VA PRE-OPERATIVE WAS 20/70 AND VA POST-OPERATIVE WAS 20/25. THERE WAS NO SUTURE(S) AND NO VITRECTOMY. PATIENT OUTCOME WAS REPORTED AS: MYOPIA OS. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING THE LENS WAS REPLACED WITH A DIFFERENT MODEL LENS, HIGHER DIOPTER (21.0). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 10318611 ↗
• InjuryApr 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INTRAOCULAR LENS (IOL), MODEL ZXT150 19.0 DIOPTER WAS IMPLANTED IN A PATIENT'S LEFT EYE (OS) AND WAS LATER EXPLANTED DUE TO PATIENT'S EXPERIENCE OF DOUBLE VISION AND AS THE WRONG LENS MODEL WAS IMPLANTED. REPORTEDLY, THE PATIENT WAS SUPPOSED TO HAVE A MONOFOCAL TORIC LENS, MODEL ZCT150 19.0 DIOPTER WHICH WAS REQUESTED, HOWEVER, A ZXT150 MODEL WAS ORDERED DUE TO AN ORDER ENTRY ERROR. THE CUSTOMER DID NOT NOTICE THE DIFFERENCE BETWEEN THE LENSES UNTIL IT WAS IN THE PATIENT'S EYE. THERE WAS NO PATIENT INJURY REPORTED. IT WAS INDICATED THAT THE PATIENT WAS DOING FINE POST OPERATIVELY AND THAT NO VITRECTOMY OR INCISION ENLARGEMENT WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8538608 ↗
• InjuryJan 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT300 19.0 DIOPTER) WAS EXPLANTED FROM PATIENT'S OPERATIVE EYE BECAUSE OF PATIENT EXPERIENCING BOTHERED EYES, PATIENT REPORTED THAT THE TWO EYES WEREN'T WORKING TOGETHER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURE REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8280064 ↗
• InjurySep 26, 2017Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available; Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZCT300 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO AN UNSPECIFIED MECHANICAL COMPLICATION OF THE IOL. THE LENS WAS REPLACED WITH THE SAME MODEL, A LARGER, 21.0 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6895858 ↗
• MalfunctionJun 23, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE OF A (B)(6) MALE PATIENT. THE IOL, INITIALLY PLACED AT 72 DEGREES, WAS NOTICED ROTATED TO 83 DEGREES, AT ONE MONTH POST-OP VISIT. REPORTEDLY, THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERES WITH THE PATIENT'S ACTIVITIES OF DAILY LIFE. NO FURTHER ACTIONS WERE REQUIRED. THE PATIENT WAS REPORTED DOING WELL. BCDVA (BEST CORRECTED DISTANCE VISUAL ACUITY) WAS 20/20 -2 OS (OCULAR SINISTER - LEFT EYE). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6664437 ↗
• InjuryAug 24, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER IMPLANTATION OF A ZCT300 INTRAOCULAR LENS (IOL) IN PATIENT'S RIGHT EYE, SHE WAS DIAGNOSED WITH MYOPIA. LENS WAS EXPLANTED AND REPLACED WITH ANOTHER DIFFERENT MODEL LENS. NO INCISION ENLARGEMENT, SUTURES OR OTHER PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5901628 ↗