TECNIS IOL ZXT150 (REF ZXT150U200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 05050474605206), received between Feb 10, 2017 and Oct 10, 2022 — classified as 35 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED IN THE RIGHT EYE, THE PATIENT EXPERIENCED TOO MUCH TROUBLE WITH HALOS AND GLARE, THEREFORE, THE IOL WAS EXPLANTED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE END-USER DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO DELAY IN PROCEDURE. DIRECTIONS FOR USER WERE FOLLOWED. THE PATIENT IS BETTER AFTER EXPLANT. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO PATIENT INJURY. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, DIU150, DIFFERENT DIOPTER OF 19.5). THE IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 15570009 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENSES (IOLS) WERE EXPLANTED FROM PATIENT'S BOTH EYES DUE TO BLURRY VISION, LIGHT SENSITIVITY, AND SEVERE HALOS. THE PATIENT WAS UNABLE TO DRIVE SINCE THE INITIAL IMPLANT. THERE WAS NO PATIENT INJURY. THE PATIENT WAS HAPPY POST-OPERATION AND STATED THAT SHE COULD SEE BETTER. THE ORIGINAL LENSES WERE DISCARDED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE LENS EXPLANTED FROM PATIENT'S RIGHT EYE AND A SEPARATE REPORT WILL BE SUBMITTED AGAINST THE LENS EXPLANTED FROM THE LEFT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 14722688 ↗
• InjuryApr 5, 2022Scratched Material; Scratched Material

  IT WAS REPORTED DURING POST-OPERATIVE EXAMINATION A SCRATCH WAS FOUND ON THE INTRAOCULAR LENS (IOL). THE DOCTOR WILL BE EXPLANTING THE LENS AND REPLACING IT WITH THE SAME MODEL LENS. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE IOL WAS EXPLANTED (B)(6)2022. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS NO ISSUES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14017105 ↗
• InjuryFeb 14, 2022Adverse 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 RIGHT EYE DUE UNBEARABLE HALOS AND GLARE. THE PATIENT TRIED TO GET USED TO THE HALOS AND GLARE AND EVEN HAD A YTTRIUM ALUMINIUM GARNET (YAG) LASER TREATMENT; HOWEVER, HE JUST COULD NOT DRIVE AT NIGHT. A VITRECTOMY, INCISION ENLARGEMENT, AND SUTURES WERE REQUIRED. PATIENT OUTCOME IS 20/20 SC (WITHOUT CORRECTION), 3 POINT NEAR VISION WITHOUT GLASSES (NVSC) EQUIVALENT OF 20/15. THROUGH FOLLOW UP, IT WAS LEARNED THE PATIENT FIRST OBSERVED HALOS AT THE 1-DAY POST-OPERATIVE (OP) VISIT. A NON-JOHNSON & JOHNSON LENS WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13529785 ↗
• InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT HE HAD THE SYMFONY INTRAOCULAR LENSES (IOLS) IMPLANTED IN BOTH EYES. RIGHT AFTER SURGERY, HE INFORMED HIS DOCTOR THAT THE GLARE AND HALOS ARE BOTHERING HIM. HE CANNOT SEE DISTANT OR NEARBY. HE WAS INFORMED THAT HE WILL NOT NEED TO WEAR GLASSES AFTER HAVING THE LENSES IN PLACE. HOWEVER, HE NOW OWN THREE PAIR OF GLASSES. HE CANNOT SEE THE STREET SIGNS WHEN DRIVING, INCLUDING DRIVING AT NIGHT. HE COULD NO LONGER DO HIS DAILY ACTIVITIES BECAUSE THE BRIGHTNESS (DAY LIGHT) IS HARD ON HIS EYES. HE CAN NO LONGER GO FISHING WITH HIS WIFE AND CANNOT DO MOST ACTIVITIES THAT THEY ONCE ENJOYED. IT WAS STATED LATER ON THAT THE DOCTOR PERFORMED LASIK ON THE LEFT EYE FIRST AND THE HALOS WENT AWAY. SUBSEQUENTLY, LASIK PROCEDURE WAS DONE ON THE RIGHT (OD) AS WELL, BUT THE RIGHT EYE HAS NOT IMPROVED. HE HAD USED EYE DROPS, BUT IT DID NOT HELP. HE DOES NOT KNOW THE NAME MAYBE "VISINE". THE DOCTOR ALSO PRESCRIBED A TYPE OF STEROID, BUT HE DOES NOT HAVE THE INFORMATION. HE THEN FOLLOWED UP WITH TWO OTHER PHYSICIANS. THEY BOTH TOLD HIM THAT IT COULD BE DANGEROUS TO HAVE THE LENS REMOVED FROM HIS RIGHT EYE. IT SEEMED THAT THE LENS ALLOWS TOO MUCH LIGHT GOING THROUGH AND THAT MAY

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 12652797 ↗
• InjuryFeb 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 IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF BLURRY DISTANCE VISION, DIFFICULTY WITH ANY INTERMEDIATE OR NEAR TASKS, AND HYPEROPIC OUTCOME. PATIENT IS ALSO UNHAPPY WITH VISUAL ACUITY (VA). PRE-OPERATIVE VA WAS REPORTED AS 20/80 CC. VA POST-OP WAS REPORTED AS 20/30 -1, 28 DAYS BEFORE EXPLANT. +.50 = 20/15 OD. ADDITIONAL INFORMATION WAS RECEIVED FROM ACCOUNT CONFIRMING, THE IOL WAS REPLACED WITH THE SAME MODEL LENS WITH A DIFFERENT DIOPTER SIZE. THE INCISION WAS SLIGHTLY ENLARGED FOR IOL EXPLANT. THERE WERE NO COMPLICATIONS DURING THE IOL EXPLANT, NO SUTURE(S), AND NO VITRECTOMY. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS PATIENT REFRACTS TO PLANO = 20/20, NV 10 POINT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 11289999 ↗
• InjuryOct 26, 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 FROM THE PATIENT¿S LEFT EYE DUE TO MYOPIA. IT WAS REPLACED WITH A MODEL ZXT150, 18.0 DIOPTER LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10738358 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT RIGHT EYE DUE TO HALOS AND GLARE CAUSING DIFFICULTY IN DRIVING AND ALSO COULD NOT READ WITHOUT THE HELP OF READING GLASSES. THE REPLACEMENT LENS IMPLANTED IS A MODEL ZCT150 20.5 DIOPTER LENS. NO ADDITIONAL SURGICAL/MEDICAL INTERVENTION REQUIRED. PATIENT IS DOING FABULOUS POST-OP 20/20. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Halo; No Code Available

  MAUDE report 10294136 ↗
• InjuryMay 21, 2020Product Quality Problem; Product Quality Problem

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF ANTERIOR DEPOSITS ON LENS AND WAS REPLACED WITH A DIFFERENT MODEL LENS WITH A DIFFERENT DIOPTER. THERE WAS NO INCISION ENLARGEMENT. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 10079745 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXT150 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO BLURRY VISION. THE PATIENT'S VISUAL ACUITY WAS NOT CLEAR. PATIENT PRE-OP 20/50-, POST-OP 20/60. THE INITIAL IOL WAS REPLACED WITH A MODEL ZXR00 IOL. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED. THE PATIENT WAS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 9478904 ↗
• InjuryOct 16, 2019Adverse 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 OPERATIVE EYE DUE TO THE PATIENT EXPERIENCING BLURRED VISION, AN UNWANTED INDUCED ASTIGMATISM. IT WAS ALSO REPORTED THAT THE PATIENT HAD A REFRACTIVE SURPRISE THAT UNINTENTIONALLY FLIPPED THE AXIS ON THE PATIENT. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. A NEW LENS WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9199057 ↗
• InjuryOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXT150 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO HYPEROPIC MISS. REPORTEDLY THE SYMPTOMS DID NOT INTERFERE WITH THE PATIENT¿S DAILY LIFE. THERE WAS NO LOSS OF 2 OR MORE LINES OF BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA), AND NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTION WAS NEEDED. THE EXPLANTED IOL WAS REPLACED WITH A LENS OF THE SAME MODEL ZXT150, BUT HIGHER DIOPTER (21.0). THERE WAS NO PATIENT INJURY, AND THE PATIENT IS DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9173910 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT150 +20.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING HYPEROPIA. THERE WERE SUTURES USED DURING THIS PROCEDURE. NO VITRECTOMY AND NO INCISION ENLARGEMENT WAS REQUIRED. LENS WITH SAME MODEL AND HIGHER DIOPTER OF +20.5 WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT WAS DOING WELL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9108822 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PERFORMED AN INTRAOCULAR LENS (IOL) EXCHANGE DUE TO PROLONGED COMPLAINTS OF DYSPHOTOPSIA. THE EXPLANTED LENS WAS EXCHANGED FOR A ZCB00 IOL AND THERE WERE NO COMPLICATIONS WITH THE EXCHANGE. NO MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8656857 ↗
• InjuryApr 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO A REFRACTIVE ERROR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8468297 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN PLACING A ZXT150 INTRAOCULAR LENS (IOL) IN THE PATIENT¿S EYE, THE POSTERIOR CAPSULE TORE AND THE SURGEON COULD NOT PLACE THE IOL IN THE CAPSULAR BAG. THE LENS WAS REMAINED IN THE EYE FOR APPROXIMATELY THREE WEEKS AND WAS THEN EXPLANTED. THERE WERE NO SURGICAL INTERVENTIONS REQUIRED SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 8406224 ↗
• InjuryFeb 14, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT AN ZXT150 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO THE PATIENT HAVING A MYOPIC OUTCOME. THERE WAS NO INCISION ENLARGEMENT AND NO COMPLICATIONS REPORTED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 19.5. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8338270 ↗
• InjuryJan 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD RESIDUAL HYPEROPIA AND REFRACTIVE ERROR AFTER THE IMPLANTATION OF MODEL ZXT150 INTRAOCULAR LENS(IOL) IN HIS LEFT EYE (OS). AS A RESULT, LENS WAS EXPLANTED. THROUGH FOLLOW-UP IT WAS LEARNT THERE WAS NO INCISION ENLARGEMENT, SUTURE OR VITRECTOMY REQUIRED AT EXPLANT. THE LENS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THE PATIENT OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8276760 ↗
• InjuryNov 16, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT150, +20.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN A SECONDARY PROCEDURE. REPORTEDLY, THERE WAS A HYPEROPIC MISS OF 1.83; PATIENT HAD PREVIOUS LASIK. THE REPLACEMENT LENS WAS A MODEL ZXT150, +22.5 DIOPTER LENS. PATIENT WAS DOING FINE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8080263 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MODEL ZXT150 TECNIS SYMFONY TORIC MULTIFOCAL IOL (INTRAOCULAR LENS) WAS TO BE EXPLANTED ON (B)(6) 2018 FROM PATIENT'S EYE. THE REASON FOR THE EXPLANT IS UNKNOWN, NOT PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7950252 ↗
• InjuryAug 30, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT150 20.0 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 NEEDED A DIFFERENT LENS DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 21.0. REPORTEDLY, THAT PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7832245 ↗
• InjuryAug 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED SHE HAD CATARACT SURGERY IN BOTH EYES (OU) IN (B)(6) 2017, DUE TO NIGHTTIME GLARE AND ASTIGMATISM. SHE HAS BEEN EXPERIENCING NIGHTTIME GLARE AND STARBURSTS SINCE THE LENSES WERE IMPLANTED. A YAG (YTTRIUM ALUMINUM GARNET) LASER PROCEDURE WAS PERFORMED ON THE LEFT EYE (OS), WHICH SHE STATED DID NOT PROVIDE ANY IMPROVEMENT. THE SYMPTOMS WERE AFFECTING HER DAILY ACTIVITIES. REPORTEDLY, THERE IS A PLAN TO HAVE THE LENSES EXPLANTED. THIS FILE REPRESENTS THE LEFT EYE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7786857 ↗
• InjuryJun 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT150, +20.0 DIOPTER) WAS EXPLANTED FROM PATIENT''S RIGHT EYE IN SECONDARY PROCEDURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7595136 ↗
• InjuryJun 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT150, +20.0 DIOPTER) WAS EXPLANTED FROM PATIENT'S LEFT EYE IN SECONDARY PROCEDURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7595123 ↗
• InjuryApr 11, 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 WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE IN A SECONDARY PROCEDURE BECAUSE OF THE PATIENT EXPERIENCING HALOS AND GLARES. REPORTEDLY, THE LENS WAS NOT LOADED PROPERLY. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT PATIENT RECEIVED A MONOFOCAL LENS AS THE REPLACEMENT. PATIENT WAS DOING GOOD AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7423981 ↗