TECNIS IOL ZCT300 (REF ZCT300U175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474553279), received between Sep 28, 2017 and Apr 8, 2021 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2021Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2020. THE IOL WAS EXPLANTED (B)(6) 2021 DUE TO SCRATCH ON LENS. PLANNED VITRECTOMY WAS PERFORMED. THERE WAS NO PATIENT INJURY AND IT WAS REPORTED THE PATIENT IS DOING FINE POST-OPERATIVELY. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE INCISION WAS ENLARGED AND SUTURE(S) USED DURING THE EXPLANT PROCEDURE WERE PLANNED. THE EXPLANTED LENS WITH REPLACED A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633404 ↗
• InjuryJan 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN EXPLANT WITH PATIENT LEFT EYE DUE TO COMPLAINING OF ANISOMETROPIA 3 WEEKS POST-OPERATIVELY. THERE WAS NO PATIENT INJURY OR SURGICAL OR MEDICAL INTERVENTIONS PERFORMED. LENS WAS IMPLANTED WITH ZCT150 19.0 AS REPLACEMENT. PATIENT WAS DOING WELL IMMEDIATELY POST-OPERATIVELY AND IS SCHEDULED FOR FOLLOW UP. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 11206114 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENTS LEFT EYE DUE TO A REFRACTIVE SURPRISE. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE REPLACEMENT LENS IS THE SAME DIOPTER BUT DIFFERENT MODEL IOL. ADDITIONAL INFORMATION RECEIVED REPORTED THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9714387 ↗
• InjuryJun 6, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT300 +17.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF WRONG POWER AND THE PATIENT EXPERIENCING SPECIFIC VISUAL ISSUES. REPORTEDLY LENS WITH SAME MODEL AND HIGHER DIOPTER OF +18.5 WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT WAS DOING WELL AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8673173 ↗
• InjuryApr 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A ZCT300 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE ON (B)(6) 2016. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO UNSPECIFIED INJURY AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THE PATIENT HAS RECOVERED FROM THE SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8534307 ↗
• InjuryDec 17, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A ZCT300 17.5 DIOPTER LENS WAS INSERTED AND REMOVED FROM THE PATIENT'S OPERATIVE EYE UNEXPECTEDLY BECAUSE IT DECENTERED AND RIPPED THE CAPSULE WHILE BEING INSERTED INTO THE EYE. THERE WAS NO INCISION ENLARGEMENT MADE, BUT A VITRECTOMY WAS PERFORMED AND 2 SUTURES WERE USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 8172327 ↗
• MalfunctionJun 22, 2018Unintended Movement; Unintended Movement

  REPORTEDLY, THE SUBJECT'S LEFT EYE (OS) ZCT300 INTRAOCULAR LENS (IOL) WAS 177 DEGREES AT THEIR REPOSITIONING SURGERY ON (B)(6) 2018, BUT NOTED TO BE AT 165 DEGREES DURING FOLLOW-UP VISIT ON (B)(6) 2018 (12 DEGREE ROTATION). THE SUBJECT IS DOING WELL. NO VISUAL COMPLAINTS AND NO ADDITIONAL REPOSITIONING ARE PLANNED AT THIS TIME. UNCORRECTED VISUAL ACUITY (VA) WAS 20/25 OU. AND BEST-CORRECTED VA RESULTS WERE 20/15 RIGHT EYE (OD), 20/20 LEFT EYE (OS) AND 20/15 FOR BOTH EYES (OU). NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT PERTAINS TO THE LEFT EYE (OS). A SEPARATE REPORT (MFR# 3011852734-2018-00108) HAS BEEN SUBMITTED TO RIGHT EYE (OD).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7631996 ↗
• InjuryMar 2, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THERE WAS INTRAOCULAR LENS (IOL) ROTATION FROM 161 TO 22 DEGREES. IOL REPOSITIONING WAS PLANNED FOR (B)(6) 2018. THERE WAS NO PATIENT COMPLICATION AND/OR RELATED INJURY. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION, INC.

  Patient problems: No Code Available

  MAUDE report 7311978 ↗
• InjuryNov 1, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT300 (17.5 DIOPTER) INTRAOCULAR LENS (IOL) WAS EXPLANTED AS THE LENS ROTATED OFF AXIS AND DUE TO COMPLAINT OF BLURRY, INADEQUATE VISION. IT WAS INDICATED THAT THE LENS WAS AN IMPROPER FIT AND THE DIOPTER WAS INCORRECT FOR THE PATIENT. THE REPLACEMENT LENS WAS A HIGHER POWER TORIC LENS, MODEL ZCT400 (16.5 DIOPTER). THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6995539 ↗
• InjuryOct 3, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (MODEL ZCT300, +17.5 DIOPTER) WAS IMPLANTED IN THE RIGHT EYE OF A (B)(6) FEMALE PATIENT ON (B)(6) 2017. REPORTEDLY, THE LENS WAS EXPLANTED ON (B)(6) 2017, BECAUSE THE PATIENT WAS NOT HAPPY WITH THE VISION AND THE LENS WAS NOTICED DISPLACED. A NON-AMO LENS WAS IMPLANTED AS A REPLACEMENT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PATIENT EXPERIENCED BLURRY VISION STRAIGHT AFTER THE IMPLANTATION OF THE TORIC LENS. REPORTEDLY, THE LENS WAS DISLOCATED DUE TO AN ANTERIOR CAPSULAR TEAR DURING THE CAPSULORHEXIS, EVEN THOUGH THE LENS WAS IN GOOD PLACE AT THE END OF THE SURGERY. DURING THE LENS EXCHANGE THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED, NO SUTURES WERE USED AND NO PATIENT INJURY WAS REPORTED. THE PATIENT OUTCOME WAS REPORTED BEING GOOD, BUT THERE WAS NO CHANGE IN VISION DUE TO A DENSE PCO (POSTERIOR CAPSULAR OPACIFICATION). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6912587 ↗
• MalfunctionSep 28, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT300 17.5 DIOPTER INTRAOCULAR LENS (IOL) THAT WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017 ROTATED 10 DEGREES AT THE 6-MONTH DOCTOR VISIT. IT WAS REPORTED THAT NO REPOSITIONING OR FURTHER INTERVENTION IS REQUIRED. THE PROTOCOL-DEFINED SLIT LAMP MEASUREMENT WAS 91 DEGREES ON (B)(6) 2017 VERSUS THE OPERATIVE PLACEMENT OF 81 DEGREES (B)(6) 2017. REPORTEDLY THE PATIENT IS DOING WELL AND THERE ARE NO OUTCOMES THAT AFFECT DAILY ACTIVITIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6901629 ↗