TECNIS IOL ZXT150 (REF ZXT150U230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05050474605268), received between Jan 30, 2018 and Nov 16, 2022 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 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 OPERATIVE EYE FOR AN UNKNOWN REASON. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Eye Injury; Visual Disturbances

  MAUDE report 15802840 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT 1MONTH VISIT A CLINICAL PATIENT GOT VERY BOTHERED BY HALOS. IT WAS ALSO STATED THAT THE PATIENT CANNOT DRIVE AT NIGHT. VISUAL ACUITY- 20/15 RIGHT EYE (OD); 20/20 LEFT EYE (OS). NO INTERVENTION PLANNED. THE PRE-OPERATIVE BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA): 20/25 OD, 20/30 OS. HOWEVER, THE SUBJECT RETURNED ON AN UNSCHEDULED VISIT. ALTHOUGH BCDVA WAS 20/20 FOR BOTH EYES (OU), YTTRIUM ALUMINUM GARNET (YAG) CAPSULOTOMY WAS PERFORMED FOR OU WHICH WAS BECAUSE OF POSTERIOR CAPSULE OPACIFICATON (PCO) OU. THE SUBJECT REPORTED BEING EXTREMELY BOTHERED BY HALOS-DRIVE AT NIGHT; VERY BOTHERED BY STARBURSTS- DRIVE AT NIGHT; EXTREMELY BOTHERED BY GLARE- COMPUTER WORK, DRIVING AT NIGHT, GLARE BOTHERS THE PATIENT OFTEN WHEN WALKING AROUND IN MY HOME BECAUSE OF LIGHT FROM WINDOWS. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE RIGHT EYE (OD). A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE (OS).

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 11181421 ↗
• InjuryAug 14, 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 OPERATIVE EYE DUE TO A +3D POST-OPERATIVE (OP) MYOPIC SURPRISE IN A POST-LASIK PATIENT. THE LENS WAS CUT IN PIECES AND DISCARDED. VISUAL ACUITY (VA) PRE-OP: 20 70, VISUAL ACUITY POST-OP: (B)(6) 2020: 2100, AND VA ON (B)(6) 2020: 2400. AN INCISION ENLARGEMENT WAS REQUIRED, HOWEVER, THERE WAS NO REPORT OF ANY MEDICAL OR SURGICAL INTERVENTION REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND LOWER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10411044 ↗
• InjuryMar 12, 2020Adverse 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 +23.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN SECONDARY SURGICAL PROCEDURE. REASON FOR EXPLANT WAS NOT PROVIDED. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND NO VITRECTOMY REQUIRED. LENS FROM ANOTHER MANUFACTURER WAS USED AS REPLACEMENT FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9822203 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BLURRED VISION DISTANCE AND NEAR POST INTRAOCULAR LENS (IOL) IMPLANT IN THE RIGHT EYE. VISUAL ACUITY PRE-OPERATIVE WAS 20/70 BAT (BRIGHTNESS ACUITY TESTER), BEST-CORRECTED VISUAL ACUITY 20/20. BEST-CORRECTED VISUAL ACUITY POST-OPERATIVE WAS 20/50. THEREFORE, AN INTRAOCULAR LENS (IOL) EXCHANGE WAS PERFORMED. THE REPLACEMENT LENS WAS A DIFFERENT MODEL AND HIGHER DIOPTER. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE PATIENT WAS VERY SATISFACTORY POST-OPERATIVELY. THE PATIENT NOW SEES 20/25. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 9561801 ↗
• InjuryDec 3, 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 LEFT EYE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS LEFT EYE.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 9406606 ↗
• InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SINCE THE PATIENT WAS UNHAPPY, THE INTRAOCULAR LENS (IOL), MODEL ZXT150 23.0 DIOPTER WAS SCHEDULED TO BE EXPLANTED FROM THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9353214 ↗
• InjuryNov 6, 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 (MODEL ZXT150 +23.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN SECONDARY SURGICAL PROCEDURE. THE REASON FOR EXPLANT WAS NOT PROVIDED. REPORTEDLY LENS WITH ANOTHER MODEL (ZXR00) AND LOWER DIOPTER OF +22.0 WAS USED AS REPLACEMENT FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9283427 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IOL WAS EXPLANTED FROM PATIENT LEFT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT EXPERIENCING WARY VISION, VISION REPORTED BLURRY AND NOT SHARP WITH SHADOWS. THERE WAS NO VITRECTOMY AND NO SUTURES REQUIRED. THE REPLACEMENT LENS IS A DIFFERENT MODEL BUT SAME DIOPTER. PATIENT/USER OUTCOME: UNCORRECTED VISUAL ACUITY (UCVA): 20/40 BEST CORRECTED VISUAL ACUITY (BCVA): 20/40. VISUAL ACUITY PRE-OP: UCVA: 20/80 BCVA: 20/25. VISUAL ACUITY POST-OP: UCVA: 20/40 BCVA: 20/40. NO OTHER INFORMATION PROVIDED.

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

  MAUDE report 8814844 ↗
• InjuryJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A ZXT150 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN A PATIENT ON (B)(6) 2018. THE PATIENT HAD ARCUATE SURGERY 20 YEARS AGO AND HAS FUCHS¿ SYNDROME. THE PATIENT REPORTS BEING FARSIGHTED AND SEES GHOST IMAGES FROM FAR AWAY. SHE ALSO REPORTS SHE HAS SCAR TISSUE. THE PATIENT IS NOT HAPPY WITH THE OUTCOME OF SURGERY. ADDITIONAL INFORMATION WAS PROVIDED. IT WAS LEARNT THAT THE PATIENT WAS TOLD THAT SHE WAS SUPPOSED TO BE ABLE TO CLEARLY SEE CLOSE-UP, INTERMEDIATE, AND DISTANCE. BUT HER VISION IS BLURRY AT ALL THREE POINTS, AS IF SHE CANNOT SEE ANYMORE. SHE CAN DRIVE OKAY DURING THE DAY BUT CANNOT DRIVE AT NIGHT. SHE CLAIMS THAT HER VISUAL SYMPTOMS SIGNIFICANTLY INTERFERE WITH HER REGULAR ACTIVITIES. SHE'S IS VERY UNHAPPY WITH HER VISUAL RESULTS. SHE SAID THAT SHE WENT TO TWO OTHER DOCTORS WHO BOTH SAY THAT HER SURGEON SHOULDN'T HAVE PUT THE IMPLANT BECAUSE SHE HAD ARCUATE SURGERY AND FUCHS¿ SYNDROME.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 8685427 ↗
• InjuryMay 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WILL UNDERGO AN INTRAOCULAR LENS (IOL) REPLACEMENT IN (B)(6) 2019 IN THE LEFT EYE (OS), DUE TO INTOLERABLE GLARE. VISUAL ACUITY: (B)(6) 2019: OS: +0.50 X -2.25 X 090 = 6/5. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8589060 ↗
• InjuryMay 3, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT150 23.0 DIOPTER LENS ROTATED POST OPERATIVELY IN THE PATIENT¿S EYE. INITIALLY IT WAS PLANNED TO EXPLANT THE LENS. HOWEVER THRU FOLLOW-UP THE CUSTOMER EXPLAINED THAT THEY DECIDED TO REPOSITION THE LENS INSTEAD.

  Patient problems: No Code Available

  MAUDE report 8578391 ↗
• InjuryMar 27, 2019Optical Decentration; Malposition of Device; Optical Decentration; Malposition of Device

  IT WAS REPORTED THAT +23.0 DIOPTER LENS MODEL, ZXT150 MULTIFOCAL IOL (INTRAOCULAR LENS) IMPLANTED IN PATIENT'S LEFT EYE (OS) HAD A POOR CENTRATION. AS A RESULT, LENS WAS REMOVED AND REPLACED WITH +21.5 DIOPTER LENS MODEL, ZMA00. IT WAS ALSO NOTED THAT AN INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. PATIENT OUTCOME WAS REPORTED AS FINE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8454783 ↗
• MalfunctionSep 27, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 7913524 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 23.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 AND REPLACED WITH A COMPETITOR LENS. THE REASON FOR THE EXPLANT IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7613110 ↗
• InjuryJun 12, 2018Adverse 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 IMPLANTED IN THE LEFT EYE OF THE PATIENT ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO UNEXPECTED POST-OP REFRACTION. THE PATIENT WAS NOT HAPPY WITH THE VISUAL OUTCOME AND SHE WAS EXPERIENCING STARBURSTS AND HALOS. THE INCISION WAS NOT ENLARGED AND THE PATIENT WAS REPORTED AS RECOVERED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7590811 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO RESIDUAL REFRACTIVE ERROR. THERE WAS NO INCISION ENLARGEMENT PERFORMED. THE REPLACEMENT LENS WAS THE SAME DIOPTER BUT A DIFFERENT MODEL (ZXR00). REPORTEDLY, THERE WAS NO PATIENT INJURY OR COMPLICATIONS AND THERE WAS NO ADDITIONAL PROCEDURES. IT WAS NOTED THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7401895 ↗
• InjuryJan 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD). IT WAS LATER EXPLANTED ON (B)(6) 2017, BECAUSE THE PATIENT COMPLAINED OF VISUAL DISTURBANCES AND HAD AN UNEXPECTED POST-OPERATIVE REFRACTION. THE LENS WAS REPLACED WITH A ZCT150 23.0 DIOPTER LENS. REPORTEDLY, THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7229615 ↗