TECNIS IOL ZXT225 (REF ZXT225U230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474605855), received between Apr 27, 2017 and Aug 11, 2021 — classified as 10 injuries, 1 malfunction.

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

• MalfunctionAug 11, 2021Inaccurate Delivery; Material Split, Cut or Torn; Inaccurate Delivery; Material Split, Cut or Torn

  IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO THE PATIENT'S EYE AND THE SURGEON NOTICED THE LENS WAS TORN IN HALF. ACCOUNT BELIEVED THAT A NON-JOHNSON AND JOHNSON VALIDATED CARTRIDGE HAD BEEN USED TO LOAD THE LENS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACKUP LENS OF THE SAME MODEL AND DIOPTER. NO ADDITIONAL SURGICAL INTERVENTION WAS PERFORMED. REPORTEDLY, PATIENT HAS RECOVERED FROM SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12308980 ↗
• InjuryAug 26, 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 DUE TO PATIENT ISSUES. THIS WAS NOTED IN THE COMPLAINT FORM AS PROBLEM WAS OBSERVED DURING POST-OPERATIVE EXAMINATION. THERE WAS INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10457865 ↗
• InjuryMay 15, 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 THE PATIENT'S LEFT EYE. THE INCISION WAS NOT ENLARGED AND THERE WERE NO OTHER SURGICAL INTERVENTION REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (DIFFERENT MODEL AND HIGHER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10063660 ↗
• InjuryMay 17, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AT THE 1-DAY POST-OP, THE PATIENT IMPLANTED WITH AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE REPORTED BLURRY VISION. THE INITIAL ORIENTATION OF THE LENS WAS 170 DEGREES AND OBSERVED DURING THE EXAM TO HAVE ROTATED TO 7 DEGREES. THE IOL WAS REPOSITIONED ROTATIONALLY AND THE PATIENTS VISION HAS IMPROVED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8618590 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS COMPLAINING OF STARBURSTS, RINGS AROUND LIGHT, GHOSTS IN HER EYE, WEDGES- AS IF THE LENS WAS TOO SMALL, AS WELL AS A BLUR. SHE NEVER WORE READING GLASSES, NOW SHE NEEDS THEM. HER EYES ARE WORSE NOW THAN PRIOR TO SURGERY, SHE WAS PROMISED SHE WOULD GET 20/30 IN HER RIGHT EYE. SHE WAS ABLE TO READ PRESCRIPTION BOTTLES AND NOW SHE CAN'T. IT¿S BEEN 3 YEARS SINCE HER SURGERY, SHE HAS BEEN THROUGH MULTIPLE EYE TESTS. SHE IS NOT VERY HAPPY. FOLLOW-UP WITH THE IMPLANTING DOCTOR WAS CONDUCTED. THE PATIENT¿S PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/50 RIGHT EYE (OD) AND 20/25- LEFT EYE (OS) WITH GLARE. HER POST OP BCVA WAS 20/25 BOTH EYE (OU). THE DOCTOR STATED THAT DESPITE EXPLAINING ALL OF THE RISKS (INCLUDING THE GLARE AND HALOES THAT THE PATIENT IS EXPERIENCING) AND BENEFITS OF MULTIFOCAL LENS IMPLANTS PREOPERATIVELY, THE PATIENT STATES THAT THEY WERE NEVER EXPLAINED TO HER. THE DOCTOR OFFERED HER IOL EXCHANGE, BUT SHE HAS REFUSED. THE DOCTOR ALSO OFFERED HER A SECOND OPINION, WHICH SHE HAS REFUSED. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE (OD).

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 8572026 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXT225 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2019. THE LENS WILL BE EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINTS OF DYSPHOTOPSIA AND VISUAL DISTURBANCE. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING REPORTED SYMPTOMS OF DYSPHOTOPSIA/VISUAL DISTURBANCE WAS FIRST NOTED ON (B)(6) 2019, ZXT225 23.0 DIOPTER IOL WAS EXPLANTED ON (B)(6) 2019, AND THE REPLACEMENT LENS WAS A ZCT225 22.5D IOL. IT WAS ALSO REPORTED THE PATIENT DID NOT HAVE ANY CONTRIBUTING MEDICAL HISTORY, THERE WERE NO COMPLICATIONS DURING THE LENS EXCHANGE, NO VITRECTOMY, AND PATIENT OUTCOME WAS REPORTED AS THE PATIENT IS HAPPY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8536346 ↗
• InjuryApr 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL), MODEL ZXT225, 23.0 DIOPTER, WAS EXPLANTED DUE TO THE PATIENT BEING UNHAPPY OF HALOS AND GLARE ISSUES. THE PATIENT HAS NO CONTRIBUTING MEDICAL HISTORY. A ZCT225 23.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THERE WERE NO SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. IT WAS INDICATED THAT THE PATIENT IS CURRENTLY DOING FINE AND THE EXPLANTED LENS WAS DISCARDED BY THE ACCOUNT. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAD A BILATERAL LENS IMPLANT. THIS REPORT IS FOR THE PATIENT'S LEFT EYE (OS). A SEPARATE REPORT WILL BE FILED FOR THE PATIENT'S RIGHT EYE (OD).

  Patient problems: Halo; No Code Available

  MAUDE report 8517529 ↗
• InjuryFeb 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 23.0 INTRAOCULAR LENS WAS EXPLANTED BECAUSE THE PATIENT WAS UNSATISFIED. ADDITIONAL INFORMATION RECEIVED REVEALED THE LENS WAS EXPLANTED ON (B)(6) 2019 FROM THE PATIENT¿S RIGHT EYE DUE TO THE PATIENT COMPLAINTS OF HAZE, GLARE AT NIGHT, AND COULD NOT FOCUS. AT EXPLANT THE CONTINUOUS CURVILINEAR CAPSULORHEXIS (CCC) SPLIT AND A THREE-PIECE LENS WAS PLACED. THERE WAS NO PATIENT INJURY POST-OP AND THE EXPLANTED LENS WAS DISCARDED.

  Patient problems: Blurred Vision; Capsular Bag Tear; No Code Available

  MAUDE report 8346377 ↗
• InjuryNov 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXT225 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2018 AND EXPLANTED ON (B)(6) 2018 DUE TO PATIENT COMPLAINT OF UNKNOWN/UNSPECIFIED VISUAL ISSUES. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), NO VITRECTOMY, AND THE REPLACEMENT LENS WAS A ZXR00 22.0 DIOPTER IOL. PATIENT OUTCOME WAS REPORTED 20/30 VISUAL ACUITY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8057310 ↗
• InjuryJul 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ZXT225 23.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM A MALE PATIENT'S LEFT EYE DUE TO PATIENT NOT BEING ABLE TO TOLERATE THE GLARE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY AND NO SUTURES WERE REQUIRED. THE LENS WAS REPLACED WITH A PCB00 IOL WITH A HIGHER DIOPTER SIZE (25.0). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6751327 ↗
• InjuryApr 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 23.0 DIOPTER INTRAOCULAR LENS (IOL) WILL BE EXPLANTED AND EXCHANGED FOR A MONOFOCAL TORIC IOL DUE TO PATIENT NOT BEING ABLE TO ADJUST TO THE SYMFONY LENS.

  Patient problems: No Code Available

  MAUDE report 6525046 ↗