TECNIS IOL ZXT150 (REF ZXT150U175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05050474605152), received between Mar 1, 2017 and Feb 13, 2023 — classified as 11 injuries, 3 malfunctions.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 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 IN THE PATIENT'S RIGHT EYE. THE PATIENT DEVELOPED HALOS AROUND LIGHT DURING THE DAYLIGHT. HE ALSO COMPLAINED ABOUT BLURRED VISION FOR BOTH DISTANCE AND UP-CLOSE VISION. CALLER CLAIMS TOTAL BLINDNESS AT NIGHT. FURTHER FOLLOW-UP STATED THAT THE HALOS DID NOT IMPROVE AND SEEM TO BE WORSE, BUT WITH GLASSES IT DOES HELP. PATIENT HAS HAD VISUAL ISSUES SINCE POST-OPERATIVE (OP) DAY 1. PATIENT CLAIMED HE HAS NO DISTANCE OR READING VISION AND ONLY MID-RANGE VISION. ABOUT 6 1/2 MONTHS LATER, THE PATIENT'S VISION IS CLEAR 2 FEET (FT.). TO 4 FT. ONLY. ANYTHING CLOSER TO 2 FT. IS OUT OF FOCUS AND ANYTHING AFTER 4 FT. IS OUT OF FOCUS. THE PATIENT ALSO COMPLAINS OF HALOS AROUND LIGHTS DURING THE DAY TIME AND SEVERE DURING THE NIGHT TIME. HE SAID THAT HE IS RETIRED, TRAVELS OFTEN, BUT CAN WATCH TV AT NIGHT. THE PATIENT LOOKED FOR A SECOND OPINION AND HIS LENS WAS EXPLANTED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 16369424 ↗
• InjuryNov 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ITS WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO VISION DISTORTION, BLURRING, UNABLE TO TOLERATE NEAR VISION POST CATARACT (B)(6) 2019. ADDITIONALLY NOTED AS A MECHANICAL COMPLICATION WITH IOL ANISOMETROPIA DUE TO DIFFERENT LENS MODELS. LENS WAS REPLACED WITH A MODEL ZKB00 LENS AND THE RESULT AS SATISFACTORY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9301489 ↗
• InjuryOct 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER INSERTING ZXT150 17.5 DIOPTER INTRAOCULAR LENS (IOL) INTO PATIENT¿S OCULAR DEXTER (RIGHT EYE) THE DOCTOR NOTICED THE CAPSULE WAS TORN. THE ZXT150 LENS WAS REMOVED AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION ANTERIOR LENS. IT WAS REPORTED THERE WAS NO PATIENT INJURY HOWEVER INCISION ENLARGEMENT AND SUTURE(S) WERE REQUIRED. PATIENT STATUS WAS REPORTED AS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 9248593 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD BILATERAL IMPLANTS ON (B)(6) 2018. A ZXT150 17.5 DIOPTER WAS IMPLANTED IN THE PATIENT''S RIGHT (OD) EYE. SHE COMPLAINS OF HALOS AND STARBURSTS THAT INTERFERE WITH HER DRIVING AT NIGHT AND LOOKING AT ANY LIGHTS. HER HEALTHCARE PROVIDER RECOMMENDED THAT SHE SEEK A SECOND OPINION FOR HER VISUAL SYMPTOMS. SHE IS SCHEDULED FOR CONSULTATION ON (B)(6) 2019. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT REPRESENTS THE RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 8571921 ↗
• InjuryMar 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT EYE (OS) HAD NO CAPSULAR SUPPORT AFTER INSERTION OF THE ZXT150 MULTIFOCAL IOL (INTRAOCULAR LENS). FOR THIS REASON, THE DOCTOR HAD TO REMOVE THE LENS AND IMPLANT A NON-JOHNSON & JOHNSON LENS AS A REPLACEMENT. IT WAS ALSO NOTED THAT A VITRECTOMY WAS PERFORMED. THE PATIENT WAS REPORTED BEING WELL POST-OP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 8394195 ↗
• MalfunctionJul 31, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT150 17.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. POST-OPERATIVELY, THE LENS ROTATED 12 DEGREES. THE PATIENT STILL HAS MORE RESIDUAL CYLINDER THAN ANTICIPATED ALONG WITH A MYOPIC OUTCOME. THE PATIENT IS WEARING GLASSES AND IS NOT HAPPY ABOUT IT. REPORTEDLY, THE PATIENT DOESN'T WISH TO DO ANOTHER SURGERY AT THIS TIME. THE PATIENT'S PRE-OPERATIVE REFRACTION WAS -2.50 X 1.50 X 168 DEGREES AND POST-OPERATIVE REFRACTION WAS -1.00 X 1.00 X 015 DEGREES, INCLUDING AN UNCORRECTED VISUAL ACUITY (UCVA) OF 20/30 AND A BEST CORRECTED VISUAL ACUITY (BCVA) OF 20/20. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7736246 ↗
• MalfunctionJul 12, 2018Break; Break

  IT WAS REPORTED THAT INTRAOCULAR LENS HAD TORN/BROKEN HAPTIC. ON PERFORMING MULTIPLE FOLLOW UP ATTEMPTS IT WAS NOT CONFIRMED IF ONLY HAPTIC WAS TORN OF OPTIC WAS TORN. THE EVENT WAS OBSERVED WHILE INSERTING INTO THE EYE. THE LENS WAS REMOVED AND REPLACED IN SAME SURGICAL PROCEDURE. CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INJURY, NO INCISION ENLARGEMENT, NO SURGICAL OR MEDICAL INTERVENTION. PATIENT WAS FINE AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7684236 ↗
• InjuryJul 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ZXT150 17.5 LENS WAS EXPLANTED FROM PATIENT'S AFFECTED EYE AND REPLACED WITH ZXT150 18.5 LENS. THE REASON OF EXPLANT IS DUE TO BLURRY VISION. IT WAS NOTED THAT THERE WAS NO PATIENT INJURY AND THERE WAS NO WOUND ENLARGEMENT DURING EXPLANT. PATIENT'S VISION HAS IMPROVED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7684213 ↗
• InjuryFeb 14, 2018Adverse 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, +17.5 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE. REPORTEDLY, THERE WAS RETINAL DETACHMENT 6 MONTHS POST OP, WHICH REQUIRED A SECONDARY PROCEDURE. LENS WAS EXPLANTED AND A VITRECTOMY PERFORMED. AN ANTERIOR CHAMBER INTRAOCULAR LENS WAS USED AS REPLACEMENT LENS FOR PATIENT. PATIENT IS IN STABLE CONDITION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Retinal Detachment; Vitrectomy

  MAUDE report 7272043 ↗
• InjuryJan 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS). IT WAS LATER EXPLANTED DUE TO A MYOPIC OUTCOME. THE REPLACEMENT LENS WAS A ZXR00 16.5 DIOPTER LENS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. REPORTEDLY, THE PATIENT IS DOING GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7226991 ↗
• InjuryJan 26, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS SYMFONY TORIC INTRAOCULAR LENS (MODEL ZXT150, +17.5 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE BECAUSE PATIENT TURNED OUT TO HAVE LESS CYLINDER THAN WAS PREDICTED. TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 WITH +16.5 DIOPTER) WAS IMPLANTED AS THE REPLACEMENT LENS FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7223354 ↗
• MalfunctionMay 30, 2017Device Damaged Prior to Use; Scratched Material; Device Damaged Prior to Use; Scratched Material

  REPORTEDLY, DURING OPENING OF THE ZXT150 17.5 DIOPTER INTRAOCULAR LENS (IOL) PACKAGE, THE TECHNICIAN NOTICED A SCRATCH ON THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6598962 ↗
• InjuryApr 22, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED WITHOUT COMPLICATIONS, IN THE LEFT EYE OF A MALE PATIENT. SIX WEEKS POST OPERATION, IT WAS NOTED THAT THE LENS WAS DISLOCATED. REPORTEDLY, THE LENS WAS REPOSITIONED IN A SECONDARY SURGICAL PROCEDURE ON (B)(6) 2017. THE LENS WAS REPORTED BEING PERFECTLY CENTERED. THE PATIENT TOLERATED THE PROCEDURE WELL, AND WAS RETURNED TO THE RECOVERY ROOM IN GOOD CONDITION. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PROBLEM FIRST OCCURRED ON (B)(6) 2017; THE DAY THE LENS WAS IMPLANTED. THE LENS KEPT FALLING OFF THE CAPSULAR BAG, THE IOL CONTINUED TO MOVE AND HAD MOVED TWICE AND ON THE THIRD TIME THE LENS WAS EXPLANTED AND REPLACED. THE LENS WAS EXPLANTED ON (B)(6) 2017. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO PATIENT INJURY WAS REPORTED. THE PATIENT WAS REPORTED DOING WELL. THE LENS WAS REPLACED WITH A DIFFERENT LENS MODEL, Z9002, AND SMALLER DIOPTRE, +16.0. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6514045 ↗
• InjuryMar 1, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AS PATIENT NEEDED A DIFFERENT SIZE DIOPTER LENS. THE LENS WAS REPLACED WITH THE SAME MODEL, A LARGER, 21.0 DIOPTER LENS. THE LENS IS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6367321 ↗