TECNIS IOL ZXT150 (REF ZXT150U195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 05050474605190), received between Jan 10, 2017 and Jul 28, 2022 — classified as 22 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING GLARE AND HALOS IN THEIR LEFT EYE (OS) RESULTING IN THE NEED FOR AN EXPLANT. THE EXPLANTED INTRAOCULAR LENS (IOL) WAS REPLACED WITH A DIFFERENT MODEL IOL (DIU150) OF THE SAME DIOPTER POWER. THERE WAS NO REPORTED PATIENT INJURY AND NO SURGICAL INTERVENTION WAS REQUIRED. VISUAL ACUITIES PROVIDED AS PRE-OPERATIVE (PRE-OP) BEST CORRECTED VISUAL ACUITY (BCVA) : 20/40, POST-OP BCVA : UNKNOWN; HOWEVER, THE INTENDED/TARGETED POST-OPERATIVE REFRACTION WAS 20/20. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 15127127 ↗
• InjuryJul 13, 2022Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. THE POWER NEEDS TO BE ADJUSTED AND THE DOCTOR PLANS ON EXPLANTING THE IOL. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION REGARDING COMPLAINT HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. 05-AUG-2021 ADDITIONAL INFORMATION RECEIVED CONFIRMING IOL WAS EXPLANTED (B)(6) 2021 AND REPLACED WITH THE SAME MODEL LENS WITH A DIFFERENT DIOPTER SIZE; THUS INDICATING A CALCULATION ISSUE AND NOT A PRODUCT ISSUE. IT WAS REPORTED THE PATIENT IS DOING GREAT POST-OP. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION REGARDING COMPLAINT HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. 20-JUN-2022 ADDITIONAL INFORMATION RECEIVED FROM DUPLICATE COMPLAINT STATING PATIENT NOT HAPPY WITH RESULTS FROM DAY 1 POST-OPERATIVE (OP). DISTANCE VISION WAS OK, HOWEVER, PATIENT WAS UNABLE TO READ. INTERMEDIATE AND NEAR VISION WAS ALSO REPORTED AS BLURRY. PATIENT FELT VISION WAS WORSE THAN PRIOR TO HER SURGERY; HYPEROPIC OUTCOME WAS ALSO REPORTED. IOL EXPLANT DATE WAS CORRECTED FROM (B)(6) 2021 TO (B)(6) 2021. THERE WAS NO PATIENT INJURY, NO VITRECTOMY PER

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 15005847 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT EXPERIENCED THE FOLLOWING: SEVERE GLARE CAUSING HIM BEING UNABLE TO DRIVE AT NIGHT; BLURRY VISION FOR DISTANCE, NEAR, AND COMPUTER RANGE; AS WELL AS LIGHT SENSITIVITY UNDER ALL LIGHTING CONDITIONS. THESE SYMPTOMS MANIFESTED RIGHT AFTER A ZXT150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT (OS) EYE. THE IOL WAS EXPLANTED AND REPLACED WITH A COMPETITOR'S LENS. THE PATIENT OUTCOME WAS REPORTEDLY EXCELLENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12443590 ↗
• InjuryJun 2, 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. THE SUSPECT PRODUCT WAS DISCARDED UPON EXPLANT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 11918201 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE DUE TO HALOS AND GLARE. THE PATIENT DEVELOPED PCO (POSTERIOR CAPSULAR OPACIFICATION) THREE MONTHS POST INITIAL SURGERY. THE REPLACEMENT LENS IS A DIFFERENT MODEL AND HIGHER DIOPTER, ZCB00 20.0 DIOPTER. AT LENS EXCHANGE SUTURES WERE REQUIRED. THE PATIENT'S POST-OPERATIVE VISUAL ACUITY WAS 20/25. THE CUSTOMER INDICATED THAT THE EXPLANTED LENS WAS THROWN AWAY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11283057 ↗
• InjuryJul 30, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT HAD AN INTRAOCULAR LENS (IOL) EXPLANTED FROM THE LEFT EYE DUE TO ANISOMETROPIA FROM MECHANICAL COMPLICATION WITH IOL. THE PRE-OP VISUAL ACUITY (VA) WAS 20/30, POST-OP 20/50. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10348232 ↗
• InjuryJul 13, 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 RIGHT EYE. IT WAS STATED THAT THE PATIENT TRIED TO ACCOMMODATE THE IOL BUT WASN¿T ABLE TO GET USED TO THE GLARE AND HALOS. THE PATIENT HAD TROUBLE ADJUSTING TO THE MULTIFOCAL PLATFORM. THERE WAS TOO MUCH GLARE, PATIENT CANNOT DRIVE. VISUAL ACUITY PRE-OPERATIVE: 20/40, 20/400 WITH GLARE TEST. VISUAL ACUITY POST-OPERATIVE: 20/25 DISTANCE, 20/30 NEAR. THE SUSPECT IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON SULCUS MONOFOCAL IOL. IT WAS NOTED THAT THIS IOL WAS CHOSEN FOR BETTER SUPPORT. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. THERE WAS NO PATIENT POST-OP INJURY. THE PATIENT IS VERY HAPPY WITH THEIR CURRENT VISION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 10268745 ↗
• InjuryJun 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THE LENS WAS EXPLANTED DUE TO COMPLAINTS OF POST-OP ASTIGMATISM, VERY DRY EYES PRE AND POST OP CAUSING BLURRED VISION AND REPLACED WITH A SYMFONY ZXR00 LENS. THERE WAS NO SERIOUS PATIENT INJURY AND NO SURGICAL INTERVENTION. DAY-1 POST OP VISION WAS REPORTED AS 20/25 AND THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE

  Patient problems: Blurred Vision; Dry Eye(s); No Code Available

  MAUDE report 10146657 ↗
• InjuryMay 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER IMPLANTED A MODEL ZXT150 (TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL) IN THE PATIENT'S RIGHT EYE. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO THE PATIENT EXPERIENCING VISUAL DISTURBANCE AND REPLACED WITH LENS OF THE SAME DIOPTER, BUT A DIFFERENT MODEL, ZA9003. AN INCISION ENLARGEMENT AND VITRECTOMY WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances; Vitrectomy

  MAUDE report 10064252 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A ZXT150 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE ON (B)(6) 2020. THE ZXT150 LENS WAS EXPLANTED, HOWEVER THE REASON FOR EXPLANT WAS NOT PROVIDED. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9857056 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED A ZXT150 INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. REFRACTION ON THIS EYE WAS -0.75 X +0.50 X 083, 20/20, J3. PATIENT COMPLAINED DISTANCE VISION WASN'T AS SHARP AS IT WAS IMMEDIATELY AFTER SURGERY AND HE WAS HAVING DIFFICULTY READING STREET SIGNS. THERE WAS NO MEDIA OPACITY NOR ANY MACULAR EDEMA. PATIENT DID HAVE MILD DRY EYES WHICH THE PATIENT HAD EVEN PRIOR TO IMPLANT AND IS UNDER TREATMENT. THE PLAN WAS TO IMPLANT AN IOL IN PATIENT'S LEFT EYE (OS); HOWEVER, LATER ON THE DOCTOR STATED THAT HE AND THE PATIENT HAVE OPTED TO WAIT AND A REPEAT REFRACTION WILL BE DONE AT THAT TIME AND A DECISION TO GO FORWARD WILL BE MADE FOR OS. PATIENT CONTINUES TO BE UNHAPPY WITH DISTANCE VISION; AND ALSO STATED THAT HE WAS NOT THRILLED WITH HIS READING VISION; BUT WAS OK WEARING GLASSES TO READ FINE PRINT. PATIENT DOESN'T LIKE HALOS AROUND LIGHTS, BUT WAS WILLING TO TOLERATE THEM IF HE CAN HAVE BETTER DISTANCE VISION IN THE OTHER (OS). ABOUT FIVE MONTHS POST-OP, INFORMATION WAS RECEIVED THAT THE SUSPECT IOL IN THE RIGHT EYE WAS EXPLANTED AND EXCHANGED FOR A SAME MODEL IOL, BUT DIFFERENT DIOPTER SIZE. IT WAS NOTED THERE WAS NO INCISION ENLARGEMENT, SUTURE

  Patient problems: Halo; No Code Available

  MAUDE report 9684806 ↗
• MalfunctionJan 22, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED A MODEL ZXT150 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2019, AND WAS PLACED AT 160 AXIS. PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/40. ON (B)(6) 2019 THE CLINICAL SITE REPORTED THE LENS WAS AT 150 AXIS, AND BCVA WAS 20/20. IT WAS REPORTED NO INTERVENTION IS PLANNED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

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

  MAUDE report 9614461 ↗
• 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 9251961 ↗
• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST IMPLANT OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED A MYOPIC MISS. THE LENS WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL LENS OF AN UNKNOWN DIOPTER. AT EXPLANT NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE REQUIRED. THE PATIENT IS REPORTED TO BE DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8756230 ↗
• InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 19.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018, DUE TO THE PATIENT EXPERIENCING SIGNIFICANT AND TROUBLING GLARE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: No Code Available

  MAUDE report 7987503 ↗
• InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 19.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THERE ARE PLANS TO EXPLANT THE LENS AT A FUTURE DATE DUE TO THE PATIENT EXPERIENCING SIGNIFICANT AND TROUBLING GLARE. THE REPLACEMENT LENS WILL BE A NON-JOHNSON AND JOHNSON LENS. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: No Code Available

  MAUDE report 7986142 ↗
• InjuryJul 16, 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, +19.5 DIOPTER) WAS EXPLANTED BECAUSE OF THE PATIENT COMPLAINING OF POOR VISION. REPORTEDLY THE INCISION WAS ENLARGED DURING THE PROCEDURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7689046 ↗
• InjuryJan 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE PATIENT COMPLAINED OF VISUAL DISTURBANCES AND BEING UNABLE TO FOCUS AND READ UP CLOSE. THE LENS WAS REPLACED WITH A DIFFERENT MODEL ZCT300, BUT THE SAME DIOPTER POWER. REPORTEDLY, THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances; Visual Impairment

  MAUDE report 7229751 ↗
• InjuryJan 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO A REFRACTIVE SURPRISE THAT INCLUDED PATIENT COMPLAINTS OF BLURRY VISION, HALOS, ITCHING OF THE OPERATIVE EYE, AND A POST-OPERATIVE VISION OF 20/100. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE REPLACEMENT LENS WAS AN AAB00 18.0 DIOPTER LENS. REPORTEDLY, THE PATIENT MAY HAVE HAD AN ALLERGIC REACTION TO THE LENS. IT WAS REPORTED THAT THE PATIENT IS VERY HAPPY WITH NEW LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Itching Sensation

  MAUDE report 7183563 ↗
• InjuryDec 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 19.5 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 VISUAL DISCOMFORT FROM HALOS AND GLARE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE REPLACEMENT LENS WAS THE SAME DIOPTER, BUT DIFFERENT MODEL ZCT150. REPORTEDLY, THERE WAS NO POST-OPERATIVE PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7147003 ↗
• InjuryJun 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED SEEING A GLOW AROUND ALL LIGHTS AND FEARS DRIVING AFTER IMPLANTATION OF A ZXT150 19.5 DIOPTER INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. THE PATIENT STATED THAT HIS PHYSICIAN ADVISED HIM THAT THEY CAN REPLACE THE LENS BUT DOES NOT GUARANTEE IT WOULD RESOLVE THE ISSUE. FURTHERMORE, HIS PHYSICIAN BELIEVES THAT HE MAY ONLY NEED READING GLASSES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 6679673 ↗
• InjuryMar 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF ZXT150 19.5 DIOPTER INTRAOCULAR LENS, THE PATIENT MOVED AND THE LENS HAD TO BE REMOVED. THE PHYSICIAN HAD TO ENLARGE THE INCISION TO BE ABLE TO IMPLANT THE NEW LENS. IT WAS ALSO REPORTED THAT THE LENS WILL NOT BE AVAILABLE FOR EVALUATION AS THE LENS WAS THROWN AWAY BY THE SURGICAL TECHNICIAN

  Patient problems: No Code Available

  MAUDE report 6421388 ↗
• InjuryMar 8, 2017Adverse 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 IN A SECONDARY SURGICAL PROCEDURE, BECAUSE THE FEMALE PATIENT COMPLAINED OF POOR VISION FOR 2 WEEKS AFTER THE ORIGINAL PROCEDURE. REPORTEDLY ANOTHER LENS WAS IMPLANTED, DIFFERENT MODEL AND DIOPTER (ZLB00, +18.0 DIOPTER). THE EXPLANTED LENS WAS DESTROYED BY THE SURGEON. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6386519 ↗
• InjuryJan 10, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT00 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO POST REFRACTIVE ISSUE OR OVER MINUS ISSUE. LENS WAS REPLACED WITH THE SAME MODEL LENS, A 18.5 DIOPTER IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6239935 ↗