TECNIS IOL ZXT225 (REF ZXT225U235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474605862), received between Feb 9, 2018 and Jan 5, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  RECEIVE REPORT INDICATING THE PATIENT IS NOT HAPPY WITH THEIR REFRACTIVE OUTCOME AFTER SURGERY IN THEIR RIGHT EYE. THREE MONTHS LATER THE PATIENT HAD A PIGGYBACK INTRAOCULAR LENS (IOL) PLACED. THE PATIENT PRESENTED WITH A DECENTERED SYMFONY IOL IN THE BAG. THE HAPTIC OF THE PIGGYBACK LENS FOLDED BACK ON THE IOL CAUSING CYSTOID MACULAR EDEMA (CME) AND CORNEAL EDEMA. THE PATIENT¿S VISION ISN'T CLEAR DUE TO RECURRENT CME. THE CORNEA IS CLEAR. THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON & JOHNSON LENS. PATIENT UNDERWENT SCLERAL FIXATION OF THE INTRA-OCULAR LENS AND DESCEMET STRIPPING ENDOTHELIAL KERATOPLASTY. THROUGH FOLLOW-UP THE CUSTOMER EXPLAINED THAT THE IOL DECENTERED AND DID NOT ROTATE. THE PATIENT WAS PLACED ON THEIR STANDARD REGIMENT OF DROPS: PRED FORTE 6X PER DAY, OFLOXACIN 4X AND PROLENSA 2X. 1 WEEK APPOINTMENT (B)(6) 2020, PF 4X, D/C OFLOXACIN, PROLENSA 2X, SHE ALSO NEEDED TO ADD COSOPT 2X DUE TO HER IOP WAS ELEVATED. 2 WEEK APPOINTMENT (B)(6) 2020, SHE PRESENTED WITH CME OD SO HER DROPS WERE CHANGED: PRED FORTE WAS STOPPED AND SHE WAS PLACED ON DUREZOL 3X, PROLENSA 2X, COSOPT 2X AND ADDED DIAMOX 125 PO BID. APPOINTMENT ON (B)(6) 2020 TREATMENT STAYS THE SAME BUT

  Patient problems: Blurred Vision; Corneal Edema; Macular Edema

  MAUDE report 11121435 ↗
• InjurySep 9, 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 BECAUSE THE PATIENT COMPLAINED OF GLARE WHEN DRIVING AT NIGHT OR WHEN WATCHING TV. IOL WAS REPLACED WITH A MODEL ZCT225 23.5 DIOPTER LENS. IT WAS STATED THAT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY OR SUTURES REQUIRED. POST-OP THE PATIENT WAS STABLE WITH A LITTLE EYE IRRITATION. IT WAS NOTED THAT THE PATIENT USED REFRESH TEARS. RESURE SEALANT WAS USED TO CLOSE THE WOUND AND IT CLOSED WELL 1 DAY POST-OP. IT WAS BELIEVED THAT THIS CAUSED THE IRRITATION. THE SUSPECT PRODUCT WAS DESTROYED AT THE FACILITY. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10506141 ↗
• InjuryApr 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN SECONDARY SURGICAL PROCEDURE. REASON FOR EXPLANT WAS PROVIDED AS FOR POWER. REPORTEDLY THERE WAS INCISION ENLARGEMENT REQUIRED DURING THE EXPLANT PROCEDURE. THERE WAS NO VITRECTOMY AND NO SUTURES REQUIRED. THE LENS WAS REMOVED IN ONE PIECE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9951990 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DISSATISFIED WITH THE INTRAOCULAR LENS (IOL) IMPLANTED IN HER RIGHT EYE. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE (B)(6) 2019. THE INITIAL SURGERY WAS SUCCESSFUL; AND ONE DAY POST OP THE LENS WAS WELL POSITIONED. THE PATIENT RETURNED FOR A POST OP VISIT, (B)(6) 2019, COMPLAINING OF POOR VISION AT ALL DISTANCES. THE LENS WAS STILL WELL POSITIONED AT THIS VISIT. PATIENT DOES NOT HAVE ANY ANATOMY ISSUE THAT CONTRIBUTED TO HER SYMPTOMS. PATIENT ADDITIONALLY REPORTED POOR VISION WITH DISTORTION AT ALL DISTANCES. HALOES AT NIGHT. THE PATIENT WAS REPORTED DOING FINE POST LENS EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 9108786 ↗
• InjuryMay 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS EXPLANTED DUE TO A REFRACTIVE ERROR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8606507 ↗
• InjuryAug 24, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A ZXT225 23.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, DUE TO AN UNEXPECTED POST-OPERATIVE REFRACTION. REPORTEDLY, THE SYMPTOMS WERE ATTRIBUTED TO AN OVER CORRECTION OF THE PATIENT'S ASTIGMATISM. THE WRONG LENS WAS SELECTED. THERE WAS NO INCISION ENLARGEMENT MADE AND THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7812717 ↗
• InjuryFeb 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 23.5 DIOPTER INTRAOCULAR LENS (IOL), WAS IMPLANTED IN THE PATIENT''S RIGHT EYE (OD) ON (B)(6) 2017. POST IMPLANT THE PATIENT EXPERIENCED MYOPIC ERROR AND RESIDUAL ASTIGMATISM. POST-OPERATIVELY, 1-3 WEEKS AFTER SURGERY, THE PATIENT''S REFRACTION WAS -0.75 X -1.00 X 90, THE UNCORRECTED VISUAL ACUITY WAS 20/100, AND THE BEST CORRECTED VISUAL ACUITY WAS 20/40. REPORTEDLY, THERE WAS A PLANNED EXPLANT/EXCHANGE TO BE PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7261838 ↗