TECNIS IOL ZXT225 (REF ZXT225U200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474605794), received between May 25, 2017 and Aug 22, 2023 — classified as 8 injuries, 3 malfunctions.

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 18, 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.

• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF ANISOMETROPIA. THE EXPLANTED IOL WAS REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS, DIFFERENT MODEL AND DIFFERENT DIOPTER SIZE LENS, DXW225 18.5 DIOPTER. THERE WAS NO CAPSULAR TEAR, NO INCISION ENLARGEMENT, NO PATIENT INJURY, AND NO SUTURE(S). PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS DOING GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 17599329 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN INTRAOCULAR LENS (IOL) EXPLANTED FROM THE PATIENT'S RIGHT EYE AS PATIENT COMPLAINED OF BLURRED VISION AT DISTANCE AND NEAR, GLARE, STARBURST. THE EXPLANTED IOL REPLACED WITH A JOHNSON AND JOHNSON LENS OF DIFFERENT MODEL AND DIOPTER SIZE (DIU150, +20.5 D). NO OTHER SURGICAL OR MEDICAL INTERVENTIONS REPORTED. THERE WAS NO ADVERSE EVENTS OR INJURY POST-EXPLANT, AND THE PATIENT OUTCOME WAS GOOD. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Flashers; Visual Disturbances

  MAUDE report 15581298 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULUS SINISTER (LEFT EYE). THE IOL WAS EXPLANTED AND IT WAS REPLACED IN A SEPARATE SURGICAL PROCEDURE DUE TO COMPLAINTS OF GLARE OF HALOS AND IS NOT ABLE TO DRIVE SAFELY AT NIGHT. PATIENT OUTCOME WAS 20/20 WITHOUT CORRECTION. PRE-OPERATIVE VISUAL ACUITY WAS 20/30, 20/50 BRIGHTNESS ACUITY TEST (BAT). PATIENT WAS TRYING TO GET USED TO THE IOL, ESPECIALLY DUE TO ITS GOOD VISUAL RESULT BUT JUST COULD NOT. THE INCISION WAS ENLARGED, BUT NO SUTURE OR VITRECTOMY WAS REQUIRED. PATIENT ALSO HAD A YTTRIUM-ALUMINUM-GARNET (YAG) CAPSULOTOMY. THE LENS WAS TO REPLACED WITH TORIC IOL IN SULCUS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13589595 ↗
• MalfunctionJun 2, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED WHEN INSERTING THE INTRAOCULAR LENS (IOL) IT TORE ON INSERTION; IOL WAS FULLY INSERTED AND REMOVED. ANOTHER LENS WITH THE SAME MODEL AND DIOPTER WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). THERE WAS NO PATIENT INJURY. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS DOING OK. PER ACCOUNT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11926093 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT COMPLAINED OF A DECREASE IN VISION, BLURRY VISION AT NEAR, AND EXPERIENCED GLARE WITH AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE. THEREFORE, THE LENS WAS EXPLANTED. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (DIFFERENT MODEL ZCU150 AND HIGHER DIOPTER 21.0) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS HAPPY WITH THE OUTCOME WITH THE USE OF READING PRESCRIPTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 11371116 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD MODERATE GLARE AND HALOS WHILE DRIVING AT NIGHT. IN THE NON-DIRECTED OCULAR VISUAL SYMPTOMS, THE SUBJECT HAD NO COMPLAINTS. THE MONOCULAR (UNCORRECTED DISTANCE VISUAL ACUITY) UCDVA - OCULAR DEXTER (OD) 20/20; OCULUS SINISTER (OS) 20/20. MONOCULAR (BEST CORRECTED DISTANCE VISUAL ACUITY) BCDVA ¿ OD 20/20; OS 20/20. THE FIRST EYE OD HAD SURGERY ON (B)(6) 2019 AND WAS IMPLANTED WITH A 20.5 D MODEL ZXT375 IOL, SERIAL NUMBER (B)(4). THE SECOND EYE OS HAD SURGERY ON (B)(6) 2019 AND WAS IMPLANTED WITH A 20.0 D MODEL ZXT225 IOL, SERIAL NUMBER (B)(4). ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT PATIENT HAD REPORTED SAME ISSUES AT 1 MONTH VISIT AS WELL. THERE IS NO SURGICAL INTERVENTION PLANNED. PATIENT¿S DAILY ACTIVITIES ARE SEVERELY AFFECTED. THIS REPORT WILL CAPTURE INFORMATION FOR PATIENT¿S LEFT EYE. ANOTHER REPORT IS BEING SUBMITTED FOR PATIENT¿S RIGHT EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 9489428 ↗
• InjuryOct 22, 2018Device Dislodged or Dislocated; Scratched Material; Device Dislodged or Dislocated; Scratched Material

  IT WAS REPORTED THAT A ZXT225, 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE (OS) DUE TO LENS DISLOCATION AND POSSIBLE SCRATCH. REPORTEDLY, LENS REMOVAL WAS BECAUSE AT THE POST-OP VISIT UNDER SLIT LAMP, THERE APPEARED TO BE A SMUDGE ON LENS, NOT APPARENT AT THE TIME OF INSERTION. THE PATIENT WAS VERY DISTRESSED AS THE OBJECTS WERE DISTORTED AND THE PATIENT COULD NOT TOLERATE THE DISTORTION. IT WAS INDICATED THAT THE PATIENT HAS EXCELLENT DISTANCE VISION AND NEAR ACUITY ON HALF. THE DOCTOR MADE A NEW INCISION (NOT AN ENLARGED INCISION) AND THE LENS WAS REMOVED AND WAS REPLACED WITH ANOTHER MANUFACTURER'S IOL (19.5 DIOPTER), NO SUTURES REQUIRED. THE PATIENT IS REPORTED TO BE DOING FINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7993333 ↗
• InjuryJan 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR HAD PLANNED TO EXPLANT A ZXT225 20.0 DIOPTER INTRAOCULAR LENS (IOL) ON (B)(6) 2017, AND REPLACE IT WITH A ZCT LENS. IT WAS INDICATED THAT THE PATIENT NOT SEEING WELL WITH THE IMPLANTED LENS. EXPLANT PLANNED; HOWEVER WAS NOT CONFIRMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7202618 ↗
• InjuryDec 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. REPORTEDLY, THE PATIENT IS CURRENTLY 3 MONTHS OUT POST-OPERATIVELY AND THERE IS A PLANNED IOL EXCHANGE TO REPLACE THE LENS WITH A TORIC IOL FOR DISTANCE, (B)(6) 2018. ALSO, THE PATIENT IS EXPERIENCING BLURRED VISION AND GLARE. FURTHER INFORMATION PROVIDED REPORTS PATIENT IS MAKING IMPROVEMENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7146634 ↗
• MalfunctionAug 21, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) ROTATED. THE DOCTOR INDICATED THAT THE IOL WAS OFF ABOUT 20 DEGREES FROM THE INTENDED TARGET. THE PATIENT¿S CURRENT REFRACTION IS 75 1.25 X 165. THE INTENDED AXIS WAS 174. THE IOL IS CURRENTLY SITTING AT 20 DEGREES. THE DOCTOR IS UNDECIDED IF HE WILL ROTATE THE IOL BECAUSE THE PATIENT'S NEAR VISION IS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6809116 ↗
• MalfunctionMay 25, 2017Premature Activation; Device Operates Differently Than Expected; Premature Activation; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING THE INSERTION OF AN INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, THE LENS SHOT OUT THE SIDE OF THE CARTRIDGE. REPORTEDLY, THERE WAS A SLIGHT PATIENT CONTACT. THE DEVICE WAS DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6593207 ↗