TECNIS IOL ZXT225 (REF ZXT225U210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05050474605817), received between Feb 3, 2017 and Jul 20, 2022 — classified as 19 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE SURGERY WENT WELL, HOWEVER, AFTER SURGERY, AN INTRAOCULAR LENS (IOL) ROTATED ABOUT 20 DEGREES IN THE PATIENT'S RIGHT EYE. IN ADDITION, THE REFRACTIVE OUTCOME WAS UNEXPECTED. THIS WILL REQUIRE THE PATIENT TO EXPLANT THE LENS. THE PATIENT STATUS IS UNKNOWN AND IT WAS ALSO REPORTED THAT IT IS UNKNOWN IF THE DAILY ACTIVITIES SIGNIFICANTLY AFFECTED. AT THIS TIME, THE LENS REMAINS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15070591 ↗
• InjuryJan 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO SEVERE GLARE ISSUE AND A DISLOCATED IOL. A VITRECTOMY WAS NOT REQUIRED; HOWEVER, A SUTURE WAS USED TO CLOSE THE WOUND. A NON-JOHNSON & JOHNSON LENS WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances

  MAUDE report 13388911 ↗
• InjuryAug 5, 2021Adverse 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 AS THE PATIENT WAS UNABLE TO FUNCTION WITH THE GLARE AND HALOS. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL INTERVENTION REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (ZCU225 MODEL AND SAME DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT OUTCOME WAS EXCELLENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12285139 ↗
• InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DOCTOR IS GOING TO EXCHANGE AN INTRAOCULAR LENS (IOL) FROM THE PATIENT¿S LEFT EYE. THE PATIENT IS A POST MYOPIC LASIK AND COULD NOT ADAPT TO HALOS. HE IS GOING TO REPLACE THE IOL WITH A TECNIS MONOFOCAL TORIC IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10932995 ↗
• InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DOCTOR EXCHANGED AN INTRAOCULAR LENS (IOL) FROM THE PATIENT¿S RIGHT EYE. THE PATIENT IS A POST MYOPIC LASIK AND COULD NOT ADAPT TO HALOS. THE EXPLANTED LENS WAS REPLACED WITH A DIFFERENT MODEL, ZCT150, BUT SAME 21.0 DIOPTER POWER. NO PATIENT POST-OP INJURY, AND NO ADVERSE EVENTS REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10932983 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WILL BE EXPLANTED FROM A POST -LASIK PATIENT AND REPLACED WITH A DIFFERENT MODEL AND POWERED LENS. FURTHER INFORMATION WAS PROVIDED AND REPORTED THAT THE PATIENT HAD A REFRACTIVE ERROR. THE LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR ANY OTHER MEDICAL OR SURGICAL INTERVENTION REQUIRED. THERE WAS NO PATIENT INJURY. ANOTHER JOHNSON & JOHNSON LENS (DIFFERENT MODEL AND LOWER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT STATES AT 1-DAY POST-OPERATIVE, VISION IS BLURRY BUT BETTER THEN BEFORE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10774773 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER ACCOUNT REPORTED THAT AFTER IMPLANTATION OF A TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL) IN THE PATIENT''S LEFT (OS) EYE, THE PATIENT HAD BEEN SEEN BY THE SURGEON 21 TIMES. THE PATIENT REPORTED ISSUES WITH SEVERE HALOS AND GLARES. THE PATIENT WAS PRESCRIBED READING GLASSES WAS GIVEN ALPHAGAN DROPS TO LOWER PRESSURE BY ALLOWING BETTER FLUID DRAINAGE FROM WITHIN THE EYE AND TO PREVENT THE PUPILS FROM DILATING. THIS WOULD HELP REDUCE THE HALOS AND GLARES DURING NIGHT DRIVING. IN ADDITION, THE PATIENT HAS BEEN GIVEN CONTACT LENS TRIALS MULTIPLE TIMES TO IMPROVE THE NEAR VISION. A YTTRIUM ALUMINUM GARNET (YAG) LASER TREATMENT WAS DONE IN (B)(6) 2019. IT WAS NOTED THAT THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. POST SURGERY, BOTH EYES ARE 20/25 J2, DISTANCE IS 20/20 OR 20/25 DEPENDING ON THE DAY. THIS REPORT REPRESENTS THE LEFT (OS) EYE. A SEPARATE REPORT IS SUBMITTED FOR THE RIGHT (OD) EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 10492273 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 INTRAOCULAR LENS (IOL) 21.0 DIOPTER WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING GLARE - VISUAL ISSUES. THRU FOLLOW-UP IT WAS ALSO REPORTED DESPITE VASC (VISUAL ACUITY SANS CORRECTION) 20/25 WITH MINIMAL RX (PRESCRIPTION), PATIENT COMPLAINED OF BLURRED VISION AND LACK OF CLARITY. PATIENT DID NOT TOLERATE GLARE WITH SPIDERWEBBING WHEN DRIVING AT NIGHT. A MONOFOCAL PLACED. GLASSES AND MAXIMIZING THE OCULAR SURFACE WERE TRIED. PATIENT WAS NEVER HAPPY WITH VISION AND SPIDERWEB/GLARE AROUND LIGHTS. VISUAL ISSUES WERE FIRST NOTED ONE-DAY POST-OP. THE CUSTOMER FURTHER CLARIFIED THE REASON FOR THE EXPLANT WAS DEFRACTIVE LENS INTOLERANCE-HALOS. A PARS PLANA VITRECTOMY WAS REQUIRED, AND THE IOL WAS REPLACED WITH A DIFFERENT IOL MODEL, ZCT150 21.5 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Vitrectomy

  MAUDE report 9537268 ↗
• InjuryDec 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNHAPPY WITH AN INTRAOCULAR LENS (IOL) DUE TO EXPERIENCING SEVERE GLARE. THEREFORE, THE LENS WAS EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9533517 ↗
• MalfunctionOct 29, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT. THE EVENT WAS RELATED TO LENS DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9252127 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT (OS) OPERATIVE EYE ON (B)(6) 2017. AT 7TH DAY POSTOP, PATIENT COMPLAINT OF BLURRY VISION AND BLACK SHADOW, AT 16TH DAY HALOS WAS REPORTED. PATIENT'S PRE AND POST-OP BEST-CORRECTED VISUAL ACUITY (BCVA): PRE: 20/40; POST: 20/20. THE FACILITY WAS INFORMED THAT THE PATIENT HAD A LENS EXCHANGE PERFORMED BY A DIFFERENT SURGEON DUE TO INABILITY TO ADJUST. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAS BILATERAL IMPLANTS. THIS REPORT REPRESENTS THE LEFT (OS) EYE AND A SEPARATE REPORT IS SUBMITTED FOR THE RIGHT (OD) EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 9242327 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) (NON-DOMINANT EYE) ON (B)(6) 2018. POST-OPERATIVELY, THE PATIENT COMPLAINED OF HAVING NO CLEAR VISION AT ANY DISTANCE, SEEING MULTIPLE IMAGES AT ALL DISTANCES, AND EXTREME HALOS AND STARBURSTS AT NIGHT. THE PATIENT ALSO COMPLAINED OF SEEING AT LEAST 3 IMAGES WHEN LOOKING AT A MAIN OBJECT (GHOST IMAGES) AT 7 AND 2 O'CLOCK AND AT DISTANCES AND THAT IT'S JUST A BLUR OVER 60 FEET. THE PATIENT ALSO SEES CONCENTRIC RINGS WHEN LOOKING AT LIGHTS AT NIGHT. THE PATIENT HAS TRIED COVERING HIS DOMINATE EYE WITH A PATCH TO SEE IF BRAIN WOULD ADAPT, BUT HAS NOT BEEN SUCCESSFUL. REPORTEDLY, IT'S BEEN 10 MONTHS POST-OPERATIVELY WITH NO IMPROVEMENT. ALSO, THE PATIENT HAS HAD A YTTRIUM-ALUMINUM GARNET (YAG) PERFORMED, BUT WITH NO IMPROVEMENT. THE PATIENT HAS ALSO STATED THAT THE ONE GOOD PART ABOUT THE LENS IMPLANTED IS THAT THE COLORS ARE NICE. THE PATIENT HAS TRIED A CONTACT LENS AND TAKING REFRESH OPTIVE ADVANCED EYE DROPS 3-4 TIMES PER DAY. ALSO, THE PATIENT SAW A SPECIALIST WHO STATED THE SURGERY LOOKED WELL AND THE LENS IS POSITIONED CAREFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 8158444 ↗
• InjuryNov 13, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT225 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT''S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT HAD POOR VISION DUE TO THE MYOPIC OUTCOME. REPORTEDLY, THE PATIENT WAS TOO MYOPIC AND COULD NOT READ UP CLOSE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 19.5. THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8063400 ↗
• InjuryOct 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD UNEXPECTED POST-OP REFRACTION AND BLURRY VISION IN HER RIGHT EYE (OD) AFTER IMPLANT OF A MODEL ZXT225 TECNIS SYMFONY TORIC MULTIFOCAL IOL (INTRAOCULAR LENS). THE LENS WAS EXPLANTED. REPORTEDLY, THE SYMPTOMS SIGNIFICANTLY INTERFERED WITH ACTIVITIES OF DAILY LIFE. THE PATIENT RECOVERED POST-OP. PRODUCT WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE SURGERY CENTER. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7932755 ↗
• InjuryAug 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 21.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE REPORTEDLY, THE WRONG DIOPTER LENS WAS IMPLANTED. THE REPLACEMENT LENS WAS A MODEL ZXR00 20.5 DIOPTER LENS. REPORTEDLY, THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7811818 ↗
• InjuryApr 26, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT225 21.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE THE PATIENT WASN''T HAPPY WITH THEIR VISION AND OPTED TO HAVE IT REPLACED. THERE WAS AN INCISION ENLARGEMENT OF 3MM MADE WITH 10 NYLON SUTURES BEING USED, BUT NO VITRECTOMY WAS PERFORMED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 19.5. REPORTEDLY, THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7467371 ↗
• InjuryMar 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE LENS WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO POST-OPERATIVE COMPLAINTS OF SEVERE GLARE DURING THE NIGHT AND DAY, WHICH REQUIRED THE PATIENT TO KEEP THE SHUTTERS CLOSED DURING THE DAY. THE PATIENT ALSO COMPLAINED OF HAVING DIFFICULTY DRIVING AT NIGHT. THE REPLACEMENT LENS WAS A SULCUS MONOFOCAL 3-PIECE LENS. PRE-OPERATIVELY, THE PATIENT HAD A FAIRLY SIGNIFICANT POSTERIOR CAPSULAR OPACITY AND THE PATIENT'S BEST CORRECTED VISION WAS 20/25 WITH A GLARE TEST SCORE OF 20/100. THE PATIENT HAS TRIED GLASSES WITH ANTI-REFLECTIVE COATING, A LASER CAPSULOTOMY, AND TREATMENT OF DRY EYES. AT EXPLANT/EXCHANGE AN ANTERIOR VITRECTOMY WAS PERFORMED AND A SUTURE WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dry Eye(s); Visual Impairment; Vitrectomy

  MAUDE report 7311992 ↗
• InjuryOct 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO PATIENT COMPLAINTS ABOUT BEING INTOLERANT TO STARBURSTS EXPERIENCED. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THERE WAS NO POST-OPERATIVE PATIENT INJURY REPORTED. THE LENS WAS REPLACED WITH A THE SAME DIOPTER OF 21.0, BUT DIFFERENT MODEL ZCT150. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6916361 ↗
• InjurySep 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED FROM A FEMALE PATIENT WHO HAD A TORIC SYMFONY LENS IMPLANTED ON (B)(6) 2017. THE EYE FELT WEEK AFTER THE SURGERY AND THE PATIENT WAS COMPLAINING ABOUT FLICKERING OF LIGHTS. REPORTEDLY, SHE HAD ISSUES FROM THE DAY OF THE IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PATIENT COULD NOT DEAL WITH THE NIGHT TIME DYSPHOTOPSIA, ESPECIALLY GLARE AROUND LIGHTS. THE PATIENT STATED THAT THIS CONDITION WAS MAKING HER SUICIDAL. THE LENS WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE. NO VITRECTOMY WAS PERFORMED, NO INCISION ENLARGEMENT AND NO OTHER INJURIES WERE REPORTED. A NON-AMO LENS WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6865136 ↗
• InjuryAug 20, 2017Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXPLANT OF A TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL), MODEL ZXT225 21.0 DIOPTER FROM THE OPERATIVE EYE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6806604 ↗
• InjuryFeb 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF ZXT225 21.0 DIOPTER INTRAOCULAR LENS (IOL) ON THE PATIENT'S RIGHT EYE; THE PATIENT EXPERIENCED SEEING COBWEBS AT NIGHT AROUND BRIGHT LIGHTS. THE PATIENT ALSO EXPERIENCED GLARE. THE PATIENT HAS NOT AGREED TO HAVE HIS SECOND EYE DONE (IOL IMPLANT) SINCE HE CAN NOT TOLERATE THE COBWEBS AND THERE IS RESIDUAL CYLINDER. PATIENT'S LAST REFRACTION WAS DONE ON (B)(6) 2016 AND WAS -.75 -1.0 AT 140 DEGREES. THE PHYSICIAN THEN PERFORMED PHOTOREFRACTIVE KERATECTOMY (PRK) ON (B)(6) 2016. POST PRK REFRACTION WAS NOT RECORDED. HOWEVER, THE PHYSICIAN STATED THE PATIENT WAS SLIGHTLY PLUS POST PRK. THE LENS REMAINS IMPLANTED; HOWEVER, A POSSIBLE EXPLANT MAY BE DONE, BUT NOTHING HAS BEEN PLANNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 6302635 ↗