TECNIS IOL ZXT225 (REF ZXT225U145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474605688), received between Dec 8, 2016 and Apr 3, 2020 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (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. How this data works · Data updated Oct 13, 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.

• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL STUDY PATIENT HAD BILATERAL TECNIS TORIC SYMFONY INTRAOCULAR LENSES (IOLS) IMPLANTED. THE SUBJECT AT A 1 MONTH VISIT REPORTED EXTREMELY THAT SHE WAS BOTHERED BY STARBURSTS WHILE DRIVING AND MODERATELY BOTHERED BY GLARE RELATED TO SCATTERED LIGHT WHILE DRIVING. IN THE NON-DIRECTED OCULAR VISUAL SYMPTOMS THE SUBJECT COMPLAINED SEVERE STARBURSTS- BOTH EYES (OU). THE MONOCULAR UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) ¿ RIGHT EYE (OD) 20/20; LEFT EYE (OS) 20/20. MONOCULAR BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) ¿ OD 20/15; OS 20/15. HOWEVER, FOR THE 6 MONTH VISIT REVEALED FINDINGS OF BCDVA: 20/20 OD; 20/15 OS, MEDICAL FINDINGS SIGNIFICANT FOR POSTERIOR CAPSULAR OPACIFICATION (PCO) OU, BUT THERE WAS NO YTTRIUM ALUMINUM GARNET (YAG) CAPSULOTOMY PLANNED. ALSO, THE SUBJECT REPORTED A COMPLAINT OF OCULAR VISUAL SYMPTOMS AS EXTREMELY BOTHERED BY STARBURSTS ¿ ¿DRIVE AT NIGHT¿; EXTREMELY BOTHERED BY GLARE RELATED TO SCATTERED LIGHT- ¿DRIVE AT NIGHT¿. IN THE NON-DIRECTED OCULAR VISUAL SYMPTOMS THE SUBJECT COMPLAINED OF BLURRED VISION/DIFFICULTY WITH VISION- OVERALL AND NEAR; MILD HALOS; SEVERE STARBURSTS AND DIFFICULTY WITH VISION IN LOW LIGHT IN THE RIGHT

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

  MAUDE report 9924392 ↗
• InjuryNov 22, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE STUDY PATIENT HAD SURGERY (B)(6) 2019. THE INTRAOCULAR LENS (IOL) WAS PLACED AT AN AXIS 072 DEGREES. POST OP, THE LENS WAS MISALIGNED THIS WAS NOTED ON (B)(6) 2019 DURING THE PATIENT'S VISIT. ALSO NOTED WAS UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) 20/50, AND BEST CORRECTED VISUAL ACUITY (BCDVA) 20/20. THE LENS WAS AT 97 DEGREES. DELTA FROM AXIS LOCATION AT SURGERY WAS 025 DEGREES AND IOL REPOSITIONING IS PLANNED FOR A LATER DATE, YET TO BE DETERMINED. THE LENS WAS IMPLANTED SUCCESSFULLY AND NO PATIENT INJURY OR COMPLICATION WAS REPORTED. FOLLOW UP WAS RECEIVED AND SYMPTOMS OF BLURRED VISION/DIFFICULTY WITH NEAR VISION, AND DRYNESS. PATIENT REPORTED SHE WAS SLIGHTLY BOTHERED BY HALOS, SLIGHTLY BOTHERED BY STARBURSTS, AND VERY BOTHERED BY POOR LOW LIGHT VISION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 9365736 ↗
• InjurySep 6, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHILE INSERTING THE ZXT225 INTRAOCULAR LENS (IOL) INTO THE EYE, THE LENS/CARTRIDGE GOT HUNG UP ON THE INCISION. THE INCISION WAS ENLARGED AND A NEW LENS OF THE SAME MODEL AND DIOPTER WAS FULLY INSERTED. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED. THERE WERE NO KNOWN PATIENT COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8969400 ↗
• MalfunctionSep 6, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S OPERATIVE EYE, BUT HAD A FOLDING/UNFOLDING ISSUE. THE LENS WAS REMOVED DURING THE SAME PROCEDURE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8968273 ↗
• InjuryJun 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT375 14.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT WAS NO HAPPY WITH THEIR VISION AND REPLACED WITH A ZXT225 14.5 DIOPTER LENS. THERE WAS AN INCISION ENLARGEMENT PERFORMED, BUT THERE WAS NO COMPLICATION DURING SURGERY. THERE WAS ALSO NO VITRECTOMY PERFORMED AND NO SUTURES WERE USED. THE LENS WAS DISCARDED BY THE CUSTOMER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7624483 ↗
• InjuryDec 8, 2016Adverse 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 RIGHT EYE DUE TO PATIENT DISSATISFACTION WITH HER NEAR VISION. INCISION WAS SLIGHTLY ENLARGED IN ORDER TO EXPLANT THE LENS SAFELY. THERE WAS NO PATIENT INJURY POST-OP. LENS WAS REPLACED WITH A ZCT225 14.5 DIOPTER IOL. THE LENSES WERE EXPLANTED FROM PATIENT'S RIGHT AND LEFT EYE. THIS REPORT WILL CAPTURE THE LENS EXPLANTED FROM THE RIGHT EYE AND SEPARATE MDR WILL BE FILED FOR THE LENS EXPLANTED FROM THE LEFT EYE.

  Patient problems: No Code Available

  MAUDE report 6153742 ↗