TECNIS IOL ZXT150 (REF ZXT150U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 05050474605213), received between Dec 2, 2016 and Jul 22, 2021 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLURRY VISION AND COULD SEE THE RINGS ON THE INTRAOCULAR LENS (IOL) WHICH WAS VERY BOTHERSOME. THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12208250 ↗
• InjuryMay 18, 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 DUE TO THE PATIENT EXPERIENCING A LITTLE BLURRINESS AND WAS COMPLAINING OF A SPARKLE/DYSPHOTOPSIA 1 DAY 1 POST-OPERATIVE (OP) VISIT. THEREFORE, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS (DIFFERENT MODEL AND SAME DIOPTER). THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Flashers

  MAUDE report 11844997 ↗
• InjuryFeb 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO BLURRY VISION AND DISLOCATION. THERE WERE NO PREVIOUS EYE CONDITIONS. PATIENT REPORTED NO ISSUES REPORTED SINCE IMPLANTATION OF THE REPLACEMENT LENS MODEL ZMA00 20.5 DIOPTER. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 11279644 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING GLARE, HALOS AROUND LIGHTS AND HEADLIGHTS AT NIGHT AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. VISUAL ACUITY (VA) PRE-OPERATIVE (OP): 20/20 BOTH EYES (OU), VA POST-OP: 20/20 OU. THE RIGHT EYE WAS SCHEDULED FOR EXPLANT ON (B)(6) 2020. THROUGH FOLLOW-UP, IT WAS CONFIRMED THE LENS WAS EXPLANTED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND LOWER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING FINE AND THE REPLACEMENT LENS WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS RIGHT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE LENS IN THE LEFT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 10538741 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EIGHT MONTHS AFTER THE IMPLANTATION OF A MODEL ZXT150 TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL), THE PATIENT IS STILL AT J10 FOR THEIR NEAR VISION. THE IOL WAS EXPLANTED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. PATIENT OUTCOME POST-OPERATIVELY WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10475395 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT¿S LEFT EYE DUE TO BOTHERSOME GLARE. THE SUSPECT IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. IT WAS STATED THAT THERE WAS NO ADDITIONAL INJURY TO THE EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9507910 ↗
• InjuryAug 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150, 20.5 DIOPTER POWER INTRAOCULAR LENS (IOL) WAS REMOVED DUE TO UNEXPECTED POST-OP REFRACTION. IOL WAS REPLACED WITH ZXT150 22.0 DIOPTER, SN: (B)(4). IT WAS STATED THAT THERE WAS NO INCISION ENLARGEMENT. THE PATIENT HAS RECOVERED WELL POST-OP. THE SUSPECT PRODUCT WILL NOT BE RETURNED. DESPITE FOLLOW-UP, NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8871734 ↗
• InjuryJun 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS IMPLANTED ON (B)(6) 2018 IN PATIENT¿S LEFT AND RIGHT EYE RESPECTIVELY. PATIENT WAS EXPERIENCING VISUAL ISSUES SUCH AS STARBURST, HAZES, RINGS AND HALOS. ALSO HAVING TROUBLE JUDGING DISTANCE AT NIGHT. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT, PATIENT NOTICED THE VISUAL SYMPTOMS IMMEDIATELY AFTER SURGERY ON DAY 1. HE HAS ONLY HAD 2 FOLLOW UP APPOINTMENTS. THE PATIENT EXPLAINED THAT DURING THE DAY, THINGS ARE FINE, AND HE CAN SEE FAR, HOWEVER, HIS NEAR VISION IS NOT SO GREAT AND CANNOT READ FROM 18-20 INCHES FROM A BOOK OR COMPUTER SCREEN. IF HE BACKS UP ABOUT 30 INCHES AWAY OR MORE, HE CAN SEE THE COMPUTER SCREEN/BOOK. THEREFORE, HE MUST HAVE READERS ON. PATIENT CANNOT DRIVE AT NIGHT AS HE EXPERIENCES HALOS AROUND LIGHTS OF ON-COMING TRAFFIC WHICH MAKES IT VERY DIFFICULT TO SEE. WHEN HE LOOKS AT STREET LIGHTS OR THE MOON, HE SEES HALOS, STARBURSTS, AND ALSO SEES RINGS/CIRCLES IN THE LENSES. IN ADDITION, WHEN HE LOOKS AT RED LIGHTS, HE SEES HALOS, STARBURSTS, AND THE CIRCLES WHICH ARE MORE EXTREMELY PRONOUNCED. HE ALSO MENTIONED DURING THE NIGHT IT IS FUZZY, HAZY, OR CLOUDY AT TIMES. P

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 8673285 ↗
• MalfunctionMay 4, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT INNER PACKAGING WAS ALREADY OPENED WHEN TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT150 +20.5 DIOPTER) WAS PULLED FROM THE BOX. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8580567 ↗
• InjuryMar 22, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF LENS MODEL, ZXT150 MULTIFOCAL IOL (INTRAOCULAR LENS) THERE WAS A MECHANICAL COMPLICATION. THE LENS WAS EXPLANTED AND REPLACED WITH +20.5 DIOPTER ZCT150 LENS. THERE WERE NO COMPLICATIONS REPORTED AFTER REPLACEMENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8446513 ↗
• InjuryMar 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING RESIDUAL REFRACTIVE ERROR. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, NO VITRECTOMY REQUIRED. A NEW LENS WAS IMPLANTED. PATIENT OUTCOME WAS REPORTED AS GOOD. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8410859 ↗
• InjuryFeb 8, 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 FROM PATIENT¿S OPERATIVE EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT EXPERIENCING ASTIGMATISM. REPORTEDLY THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES REQUIRED. PATIENT OUTCOME IS GOOD. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8319259 ↗
• InjuryDec 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL ZXT150 (20.5 DIOPTER) WAS EXPLANTED DUE TO PATIENT'S DISSATISFACTION. PATIENT EXPERIENCED BLURRY, OUT OF FOCUS VISION IN BOTH EYES (OU) SINCE IMPLANT. REPORTEDLY, THE PATIENT VEHEMENTLY COMPLAINED THAT HER VISION WAS WORSE THAN BEFORE THE CATARACT SURGERY AND THAT SHE COULD NOT READ WITHOUT GLASSES; INTERMEDIATE VISION, SITTING ACROSS FROM SOMEONE, IS A BIG BLUR; AND THAT HER VISION GOES IN AND OUT OF FOCUS. THE PATIENT WAS VERY FRUSTRATED, HAD TROUBLE PERFORMING EVERY DAY TASKS, AND REPORTED THIS AFFECTED HER LIFE. AT EXPLANT, THE INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. VISUAL ACUITY PRE-OPERATIVE: LEFT EYE (OS): 20/40; VISUAL ACUITY POST-OPERATIVE: LEFT EYE (OS): 20/40; OS-GLARE 20/200. NO FURTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO PATIENT'S LEFT EYE (OS). A SEPARATE REPORT IS BEING FILED FOR THE PATIENT'S RIGHT EYE (OD).

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

  MAUDE report 8122919 ↗
• InjuryNov 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT150, +20.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S OPERATIVE EYE BECAUSE OF PATIENT EXPERIENCING INTOLERABLE GLARE. REPORTEDLY, THE LENS WAS REPLACED WITH THE DIFFERENT MODEL, A ZCB00, +21.5, A LARGER DIOPTER. PATIENT WAS DOING GOOD. THERE WAS NO INCISION ENLARGEMENT, NO PATIENT INJURY, NO VITRECTOMY PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8062627 ↗
• InjuryAug 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXT150 +20.5 DIOPTER MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE LENS WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT WAS EXPERIENCING VISUAL DISTURBANCES. A COMPETITOR LENS WAS IMPLANTED AS A REPLACEMENT. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO PATIENT INJURY OCCURRED. THE PATIENT WAS REPORTED AS RECOVERED AND DOING FINE POST-SURGERY. THE EXPLANTED LENS WAS DISCARDED BY THE SURGERY CENTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7826252 ↗
• InjuryAug 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 20.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT DID NOT LIKE THE LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES. THE REPLACEMENT LENS WAS THE SAME DIOPTER, BUT DIFFERENT MODEL ZCT150. REPORTEDLY, THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION AS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7822937 ↗
• InjuryMay 19, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT150 20.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE LENS ROTATED 6-8 DEGREES COUNTER CLOCKWISE POST-OPERATIVELY. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A MODEL ZXT225 21.5 DIOPTER. THERE WAS NO PATIENT INJURY AND THE PATIENT IS REPORTED TO BE DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7528311 ↗
• InjuryFeb 12, 2018Adverse 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 (MODEL ZXT150, +20.5 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE BECAUSE OF PATIENT COMPLAINING OF STARBURST AT NIGHT AND POOR VISION. DURING THE EXPLANT PROCEDURE INCISION ENLARGEMENT WAS PERFORMED AND A NON-AMO LENS WAS IMPLANTED AS A REPLACEMENT LENS FOR THE PATIENT. PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7265491 ↗
• InjuryJan 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 20.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT''S RIGHT (OD) EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE PATIENT COULD NOT SEE AS EXPECTED AND HAD VISUAL DISTURBANCE ISSUES WITH NEAR VISION. THE PATIENT ALSO HAS ANGLE KAPPA. THE REPLACEMENT LENS WAS A ZCT150 20.5 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7166639 ↗
• InjuryNov 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A TECNIS SYMFONY TORIC MODEL ZXT150 20.5 DIOPTER INTRAOCULAR LENS (IOL) WAS PLANNED FOR EXPLANT FROM A PATIENT¿S OPERATIVE EYE AS THERE WAS DISSATISFACTION WITH THE PATIENT¿S NEAR VISION AND EXPERIENCING HALOS. THE PATIENT WAS INITIALLY TREATED WITH EYE DROPS AND ARTIFICIAL TEARS BUT WAS NOT SATISFIED. THE PLANNED EXPLANT WAS FOR AN EXCHANGE WITH A STANDARD IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Impairment

  MAUDE report 7043130 ↗
• InjuryAug 31, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED A ZXT150 20.5 DIOPTER WAS IMPLANTED ON (B)(6) 2017 AND LATER EXPLANTED ON (B)(6) 2017 BECAUSE AN INCORRECT POWER WAS SELECTED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 19.5. ALSO, IT WAS REPORTED THAT THE EXPLANTED LENS WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6836851 ↗
• InjuryMar 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THEN NOTED THAT THE ''WRONG LENS WAS IMPLANTED''. THE LENS WAS EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6379664 ↗
• InjuryDec 2, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT150 20.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO WRONG LENS POWER. IT WAS REPORTED THAT THERE WERE NO PRODUCT ISSUES, THE PHYSICIAN MISCALCULATED THE LENS POWER. THE LENS WAS REPLACED WITH ANOTHER SYMFONY LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6142389 ↗