TECNIS IOL ZCT300 (REF ZCT300U220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474553361), received between Nov 8, 2016 and Oct 17, 2020 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (6 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.

• InjuryOct 17, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF LENS ROTATION. THE INCISION WAS ENLARGED. THERE WAS NO SUTURE(S) AND NO VITRECTOMY. THE LENS WAS DISPOSED AND IS NOT BEING RETURNED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE LENS ROTATED 13 DEGREES AND PATIENT REPORTED BLURRY VISION. A JJSV LENS WITH DIFFERENT MODEL AND DIOPTER SIZE WAS IMPLANTED. PATIENT OUTCOME WAS REPORTED AS VISION DOING OK ADJUSTING WITH SOME IRRITATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10694670 ↗
• InjuryApr 21, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT WHILE INSERTING THE LENS INTO THE EYE, AS THE LENS OPENED THE CAPSULAR BAG WAS NOTED TO BE TORN AND THE LENS WAS DRIFTING OUT OF POSITION AND TILTING INFERIOR. THE LENS WAS REMOVED AND AN ANTERIOR VITRECTOMY WAS PERFORMED. THERE WAS NO MENTION IF THIS ISSUE WAS DUE TO THE LENS. THERE WAS NO PATIENT INJURY. LENS FROM ANOTHER MANUFACTURER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. THE EXPLANTED LENS WAS DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 9983398 ↗
• InjuryOct 15, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTRAOCULAR LENSES (IOLS) ROTATIONS. THE DOCTOR MENTIONED IT WAS ABOUT FOUR (4) TO FIVE (5) PATIENTS DURING A CONVERSATION HE HAD WITH THE JOHNSON & JOHNSON ACCOUNT EXECUTIVE. THE DOCTOR STATED THE EVENTS HAPPENED OVER THE LAST FEW MONTHS, AND WAS WITH THE USE OF MODEL ZCTXX INTRAOCULAR LENSES. REPORTEDLY, THE LENSES HAD ROTATED 10-15 DEGREES. DOCTOR REQUESTED A CONSULTATION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT REPRESENTS PATIENT #2. ADDITIONAL REPORTS WILL REPRESENT THE OTHER PATIENTS.

  Patient problems: No Code Available

  MAUDE report 9193678 ↗
• MalfunctionFeb 8, 2019Contamination; Adverse Event Without Identified Device or Use Problem; Contamination; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING HANDLING AND PRIOR TO THE INTRAOCULAR LENS (IOL) INSERTION, THERE WAS CONTAMINATION. FURTHER INFORMATION WAS PROVIDED, WHERE IT WAS STATED THAT THE LENS WAS CHANGED BECAUSE THE PREVIOUS LENS WAS CONTAMINATED AND UNABLE TO INSERT INTO THE EYE. THERE WAS NO PATIENT CONTACT AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8324289 ↗
• InjuryOct 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE TECNIS TORIC MONOFOCAL INTRAOCULAR LENS (MODEL ZCT300 +22.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE PATIENT WANTED MULTIFOCALITY. THE DOCTOR UPGRADED TO A TECNIS MULTIFOCAL LENS, A MODEL ZMB00, +22.0 DIOPTER. PATIENT WAS DOING WELL UPON DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7945644 ↗
• MalfunctionNov 10, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT300 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS). POST-OPERATIVELY 6 MONTHS AFTER THE IMPLANTATION, ON (B)(6) 2017, THE IOL ROTATED FROM IT'S ORIGINAL AXIS AT IMPLANTATION OF 115 DEGREES TO 100 DEGREES AT SIX (6) MONTHS POST IMPLANT. THE MISALIGNMENT WAS 15 DEGREES. REPORTEDLY, THERE WAS NO PATIENT COMPLICATIONS OR INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7022590 ↗
• MalfunctionSep 20, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE RIGHT EYE OF A (B)(6) MALE PATIENT. THE LENS ORIGINALLY PLACED AT 95 DEGREES, WAS MEASURED AT THE SIX-MONTH POST-OPERATION VISIT, AT 75 DEGREES. REPORTEDLY, NO REPOSITIONING OF THE LENS OR ANY FURTHER INTERVENTION WAS REQUIRED. THE LENS REMAINS IMPLANTED IN THE EYE AND THE PATIENT WAS REPORTED DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6881588 ↗
• InjuryJun 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT300 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED AS THE PATIENT WAS EXPERIENCING GLARE AROUND LIGHTS AND WAS ADJUSTING WELL TO THE LENS. SURGERY WENT SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 6659033 ↗
• MalfunctionMay 26, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE OF A (B)(6) FEMALE PATIENT. THE LENS, INITIALLY PLACED AT 90 DEGREES, WAS MEASURED AT 80 DEGREES AT THE SIX MONTH POST-OP VISIT, WITH A MISALIGNMENT OF 10 DEGREES. BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) 20/20 IN BOTH EYES (OU). REPORTEDLY, THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH THE PATIENT'S ACTIVITIES OF DAILY LIFE. NO LENS REPOSITION OR FURTHER INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6593266 ↗
• MalfunctionDec 12, 2016Unintended Movement; Unintended Movement

  DURING A STUDY VISIT, PATIENT INTRAOCULAR LENS (IOL) MEASUREMENT WAS PERFORMED AND THE SLIT LAMP MEASURED THE IOL AT 29 DEGREES. WHICH WAS 14 DEGREES FROM THE OPERATIONAL PLACEMENT OF 15 DEGREES. THERE WAS NO PHYSICIAN OR PATIENT COMPLAINT. PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) IS 20/20 OD (RIGHT EYE). THE IOL REMAINS IMPLANTED. THERE WERE NO IMPAIRMENT REPORTED AND THE SURGERY OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH PATIENT'S ACTIVITIES OF DAILY LIFE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6165575 ↗
• InjuryNov 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT HAD A MILD PRESENTATION OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AFTER IMPLANTATION OF A MODEL ZCT300 22.0 DIOPTER INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE. INFLAMMATION 1ST DAY POST OPERATIVELY WAS NOTED. ALSO NOTED IS IMPLANTATION OF A MORCHER CAPSULAR TENSION RING. THE IOL REMAINS IMPLANTED AND THE TASS WAS STATED TO HAVE RESOLVED. VISUAL ACUITY IS 20/40 UNCORRECTED AND 20/25+ CORRECTED. THE PATIENT'S CURRENT STATUS IS INDICATED AS RECOVERED.

  Patient problems: Inflammation; No Code Available; Pain; Red Eye(s)

  MAUDE report 6087230 ↗