TECNIS IOL ZXT150 (REF ZXT150U180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05050474605169), received between Apr 5, 2017 and Jun 16, 2021 — classified as 19 injuries, 2 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. 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A SYMFONY TORIC IOL BACK IN (B)(6) 2021. SHE WAS EXPERIENCING DYSPHOTOPSIAS THAT SHE WAS UNHAPPY WITH AND WANTED LENS EXCHANGED. THE LENS EXTRACTION WAS PERFORMED. DOCTOR USED A DIU225 19.0D AS A REPLACEMENT LENS. THERE IS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 12014214 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF A TECNIS SYMFONY INTRAOCULAR LENS (IOL), THE PATIENT COMPLAINED THAT THE LENS IS NOT PROVIDING CLEAR VISION AT DISTANCE OR NEAR. THE PATIENT DID HAVE POSTERIOR CAPSULE OPACIFICATION (PCO) THAT THE SURGEON THOUGHT WAS CAUSING THE BLURRINESS. HOWEVER, THERE WAS NO IMPROVEMENT TO THE VISION AFTER YTTRIUM ALUMINUM GARNET (YAG) LASER TREATMENT COMPLETED. VISUAL ACUITY (VA) FOR THE LEFT EYE (OS) PRE-OP WAS 20/30 AND POST-OP IS 20/40. NEAR VISION IS 20/20 FOR BOTH EYES (OU). LENS REMAINS IMPLANTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11556278 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH TECNIS SYMFONY LENSES BILATERALLY ON (B)(6) 2019 AND (B)(6) 2019. THE PATIENT WAS EXPERIENCING HAZE AND GLARE WITH LIGHTS AT NIGHT AND WAS UNABLE TO DRIVE. SURGEON EVALUATED THE PATIENT AND DECIDED TO EXCHANGE THE LENS FOR A REGULAR LENS. SURGEON EXPLANTED LENS FROM PATIENT¿S RIGHT EYE ON (B)(6) 2020 AND LEFT EYE WAS SCHEDULED TO BE EXPLANTED ON (B)(6) 2020. THE VISUAL ACUITY PRE-OP WAS REPORTED AS 20/30 AND POST OP VISUAL ACUITY WAS REPORTED AS 20/20. REPORTEDLY TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT150 +18.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE AS PLANNED. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND NO VITRECTOMY REQUIRED. THIS REPORT WILL CAPTURE INFORMATION ABOUT PATIENT¿S LEFT EYE AND A SEPARATE REPORT HAS BEEN SUBMITTED FOR PATIENT¿S RIGHT EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9887336 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS VERY UNHAPPY WITH HER READING VISION POST IMPLANT OF A SYMFONY INTRAOCULAR LENS (IOL). PRE-OPERATIVE VISUAL ACUITY 20/50 AND POST-OPERATIVE VISUAL ACUITY 20/25. THE PATIENT WAS PREVIOUSLY A MONOVISION PATIENT AND HER READING IS UNACCEPTABLE. SYMPTOMS WERE DESCRIBED AS BLURRED VISION WHILE READING. THE SYMFONY IOL WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE AND REPLACED WITH A TECNIS TORIC IOL. THE EXPLANTED LENS WAS DISCARDED ONCE IT WAS BISECTED AND REMOVED FROM THE EYE. AT EXPLANT THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. AT 1-DAY POST-EXCHANGE, THE PATIENT WAS EXPERIENCING BLURRY VISION 2/2 CORNEAL EDEMA. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 9464570 ↗
• InjuryNov 5, 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 IMPLANTED IN THE RIGHT EYE OF A PATIENT. BUT THE PATIENT NOW CANNOT READ AT ALL (VISUAL ACUITY OF 20/80) AND THE CUSTOMER CLAIMED THAT THEY HAVE EXHAUSTED ALL AVENUES OF EXPLANATION AND CANNOT COME UP WITH A REASON. THE PATIENT DOES HAVE MILD POSTERIOR CAPSULAR OPACIFICATION (PCO), BUT NOT ENOUGH TO BE VISUALLY SIGNIFICANT. THE PATIENT ALSO REFRACTS TO +0.75 -1.00 X 90, BUT STILL CANNOT READ EVEN WITH THE DISTANCE CORRECTION. IT WAS LEARNED THAT THE PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/50, AND POST-OP WAS 20/20. THERE WAS NO PLAN TO REMOVE THE IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 9277099 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AT THE SUBJECT'S 6 MONTH VISIT, THE SUBJECT WAS MODERATELY BOTHERED BY HALOS, STARBURSTS, AND GLARE. THE SUBJECT IS NOT DRIVING AT NIGHT. THE SYMPTOMS INTERFERE WITH DAILY ACTIVITIES. HOWEVER, THE INTRAOCULAR LENS (IOL) REMAINS IMPLANTED WITH NO INTERVENTION PLANNED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT CAPTURES THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8938543 ↗
• InjuryMay 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING MONOCULAR DIPLOPIA AND GHOSTING IN THE RIGHT EYE. REPORTEDLY, THE SURGEON NOTICED A TILT AND DECENTRATION OF THE INTRAOCULAR LENS (IOL) POST IMPLANT. THE SURGEON WAS PLANNING TO DO A REALIGNMENT BUT UPON EXAMINING THE PATIENT, THE SURGEON DECIDED TO EXPLANT THE LENS DUE TO A CAPSULAR RENT AND REPLACE THE LENS WITH A TECNIS MULTIFOCAL IOL. THROUGH FOLLOW UP, IT WAS LEARNED THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY REQUIRED. THE PATIENT IS REPORTED DOING GREAT WITH NO COMPLAINTS OR ISSUES. THE EXPLANTED IOL HAS BEEN DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Capsular Bag Tear; No Code Available; Visual Disturbances

  MAUDE report 8630360 ↗
• InjuryMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL ZXT150 +18.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE (OS) DUE TO A REFRACTIVE VISUAL ERROR. REPORTEDLY, THE PATIENT'S EYE WAS SLIGHTLY OFF TARGET, MORE NEARSIGHTED WITH RESIDUAL ASTIGMATISM. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. A ZXR00 +17.5 DIOPTER LENS WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED DOING FINE POST LENS EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8593053 ↗
• MalfunctionMay 4, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A SYMFONY TORIC LENS HAD ROTATED, (B)(6) 2019, REQUIRING SURGICAL REPOSITIONING. LENS WAS IMPLANTED IN THE LEFT EYE. ROTATED APPROXIMATELY 90 DEGREES COUNTER CLOCKWISE AND THE LENS WAS REPOSITIONED (B)(6) 2019. VISION WAS 20/20 AFTER BEST CORRECTED WITH -1.75 DIOPTER CYLINDER. NO COMPLICATIONS OR INCISION ENLARGEMENT. REPOSITION CASE WAS SUCCESSFUL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8580811 ↗
• InjuryApr 30, 2019Break; Dent in Material; Break; Dent in Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT RIGHT EYE DUE TO A VERTICAL DEFECT IN OPTIC. THE COMPLAINT IOL WAS NOT RETURNED. REQUESTS WERE MADE FOR ADDITIONAL INFORMATION BUT NO RESPONSE WAS PROVIDED BY THE ACCOUNT. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8567285 ↗
• InjuryApr 24, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED ZXT150 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(9) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINT OF MECHANICAL COMPLICATION. IT WAS REPORTED THERE WAS NO REQUIRED MEDICAL INTERVENTION, THE REPLACEMENT LENS USED WAS A NON-JOHNSON & JOHNSON SURGICAL VISION IOL. OUTCOME WAS REPORTED AS PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8547592 ↗
• InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED A BILATERAL INTRAOCULAR LENS (IOL) IMPLANT. SOON AFTER THE IMPLANTATION, THE PATIENT STARTED COMPLAINING THAT HIS VISION WAS GETTING WORSE. REPORTEDLY, THE PATIENT HAS BEEN EXPERIENCING BLURRY VISION AT ALL DISTANCES THAT IS SIGNIFICANTLY AFFECTING HIS ABILITY TO PERFORM ACTIVITIES SUCH AS DRIVING ESPECIALLY AT NIGHT. THE LENS REMAINS IMPLANTED AND THE SURGEON MENTIONED PERFORMING A YAG (YTTRIUM ALUMINUM GARNET) TO HELP IMPROVE THE VISION BUT THERE IS NOTHING PLANNED/SCHEDULED AS THIS TIME. NO ADDITIONAL INFORMATION WAS RECEIVED BY JOHNSON AND JOHNSON SURGICAL VISION. THIS MDR CAPTURES THE EVENT FOR THE LEFT EYE (OS). A SEPARATE MDR WILL BE FILED FOR THE RIGHT EYE (OD).

  Patient problems: Blurred Vision

  MAUDE report 8490683 ↗
• InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SYMFONY TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE PATIENT WAS UNHAPPY WITH HIS VISION. THE EXPLANTED LENS WAS REPLACED WITH A MODEL ZLB00 MULTIFOCAL LENS WITH THE SAME DIOPTER POWER. PATIENT OUTCOME WAS NOTED BY THE REPORTER AS HAVEN''T HEARD OF ANYTHING ADVERSE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8454753 ↗
• InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 18.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO UNKNOWN REASONS. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 16.0. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8177065 ↗
• InjuryAug 2, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT150 18.0 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 EXPERIENCED BLURRY VISION. THERE WAS NO INCISION ENLARGEMENT AND THE REPLACEMENT LENS WAS THE SAME MODEL, BUT A DIFFERENT, LARGER DIOPTER OF 19.5. REPORTEDLY, THE PATIENT'S VISION HAS IMPROVED AND THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7745484 ↗
• InjuryJul 25, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INTRAOCULAR LENS, (MODEL ZXT150 +18.0 DIOPTER) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018, AND REPLACED WITH A MODEL ZXT150 +19.0 DIOPTER, BECAUSE OF THE PATIENT COMPLAINING OF POOR VISION. THE LENS IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7719211 ↗
• InjuryMay 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 18.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO PATIENTS COMPLAINTS OF EXCESSIVE HALOS, STARBURST, AND COLOR ISSUES. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. THERE WAS NO PATIENT INJURY AND THE PATIENT STATES THEIR VISION HAS IMPROVED SINCE EXCHANGING THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7507121 ↗
• MalfunctionOct 9, 2017Fracture; Scratched Material; Fracture; Scratched Material

  IT WAS REPORTED THAT A ZXT150 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS SCRATCHED DURING IMPLANTATION AND AN UNSPECIFIED SURGICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 6933652 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF SEVERE NIGHT GLARE AND HALOS. THE INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY PROCEDURE. THE LENS WAS REPLACED WITH A MODEL ZCB00, 18.5 DIOPTER. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT WAS REPORTED AS DOING GOOD POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 6692174 ↗
• InjuryMay 19, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT150 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT NOT BEING SATISFIED. THERE WAS NO HARM TO PATIENT REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6580173 ↗
• InjuryApr 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT HAD REPORTED HAVING CONCERNS WITH GLARE AFTER IMPLANT OF A SYMFONY INTRAOCULAR LENS (IOL) IN HER LEFT EYE. SHE ALSO STATED THAT SHE IS CONSIDERING GETTING HER SECOND EYE DONE. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE PHYSICIAN WILL LIKELY PERFORM A LENS EXCHANGE. THE PATIENT IS 20/20 FOR NEAR AND FAR IN THE FIRST EYE BUT PATIENT SAYS SHE CANNOT DRIVE AT NIGHT DUE TO VISUAL SYMPTOMS. AFTER WAITING 3 MONTHS WITHOUT MUCH IMPROVEMENT, PATIENT REQUESTED IOL EXCHANGE FOR A STANDARD TORIC IOL. UNFORTUNATELY, THE IOL EXCHANGE ATTEMPT WAS UNSUCCESSFUL. THE PHYSICIAN ATTEMPTED TO FREE THE IOL USING VARIOUS TECHNIQUES, BUT THE ANTERIOR AND POSTERIOR CAPSULE LEAFLETS WERE FUSED PERIPHERALLY, AND WOULD NOT SEPARATE WITH MULTIPLE ATTEMPTS FROM DIFFERENT ANGLES OF APPROACH. THE SURGEON FELT THE SYMFONY TORIC LENS COULD NOT BE EXPLANTED SAFELY WITHOUT CAUSING SIGNIFICANT DAMAGE TO SURROUNDING OCULAR TISSUES AND ZONULES, SO DECIDED TO LEAVE THE IOL IN POSITION. NO INCISION ENLARGEMENT WAS NEEDED AND A 10-0 NYLON SUTURE WAS USED TO CLOSE THE CORNEAL INCISION AS PART OF HER NORMAL TECHNIQUE. THE STRATEGY NOW ACCORDING TO THE DOCTOR WILL BE TO OPERATE ON THE RIGHT EYE, WHICH ALSO HAS A CAT

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6461048 ↗