TECNIS IOL ZXT300 (REF ZXT300U220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474606425), received between Feb 3, 2017 and Mar 18, 2023 — classified as 9 injuries, 1 malfunction.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD BILATERAL LENS IMPLANTS, AFTER THE SURGERY EXPERIENCED PAIN IN EYE WHICH FELT LIKE WOOD IN THEIR EYES. DRYNESS WITH BLURRY SCALY FEELING. FOR MONTHS PATIENT UNABLE TO DRIVE AT NIGHT BECAUSE OF GLARE IN EYESIGHT AND DECREASED EYESIGHT. DIAGNOSED WITH SIGNIFICANT POSTERIOR CAPSULAR OPACIFICATION (PCO), YAG DONE IN LEFT EYE (OS). RIGHT EYE (OD) IMPLANT WAS EXPLANTED DUE TO MECHANICAL COMPLICATIONS OF THE INTRAOCULAR LENS (IOL). FURTHER REVIEW HOWEVER NOTED FROM THE PATIENT CHART PROVIDED THAT EVENT STARTED AS BILATERAL CATARACT EXTRACTION. OS WAS IMPLANTED FIRST. HOWEVER, AT ONE MONTH POST-IMPLANT OF OS, LENS FOR RIGHT EYE (OD) WAS ALSO IMPLANTED DUE TO EXISTING CATARACT, DRY EYE SYNDROME AND OPEN ANGLE GLAUCOMA. VISION WAS GOOD FOR BOTH EYES (OU), FAIRLY STABLE. VISUAL ISSUES (INCLUDING BURRY, GLARE, HALO AND DECREASE IN VISION), THIS TIME ALSO INCLUDING STARBURST WHEN DRIVING AT NIGHT OCCURRED IN OU. AFTER ISSUES OF NOT GETTING BETTER, PATIENT WAS REFERRED TO ANOTHER DOCTOR TO EXPLANT OD. OD WAS EXPLANTED AS PATIENT PREFERS DISTANCE WITH MONOFOCAL. ORIGINAL LENS WAS REPLACED WITH A ZCU300 LENS, SAME DIOPTER SIZE AS ORIGINAL LENS. AT ONE DAY POS

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Flashers; Halo; Visual Disturbances

  MAUDE report 16570127 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXT300 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE. THE ZXT300 22.0 DIOPTER LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINTS OF MYOPIC REFRACTIVE SURPRISE. THE PATIENT IS -1.00 + 0.75 AND IS COMPLAINING OF BLURRY DISTANCE VISION. VISUAL ACUITY (VA) PRE-OP AND POST-OP 20/30. 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: Blurred Vision; No Code Available

  MAUDE report 9486096 ↗
• InjurySep 26, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT300 22.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT EXPERIENCED POOR VISION AND REPORTEDLY, THE INCORRECT LENS POWER WAS IMPLANTED ORIGINALLY. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. 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; Visual Impairment

  MAUDE report 7912692 ↗
• InjuryJul 3, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL ZXT300 +22.0 DIOPTER) WAS IMPLANTED INTO THE LEFT EYE OF THE PATIENT ON (B)(6) 2018. ONE DAY POST-OP THE PATIENT REPORTED BLURRY VISION. REPORTEDLY, THE LENS WAS EXPLANTED ON (B)(6) 2018 AND REPLACED WITH A ZXT225 +21.0 DIOPTER BECAUSE THE SURGEON PICKED THE WRONG POWER FOR THE ORIGINAL LENS. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO PATIENT INJURY WAS REPORTED. THE EXPLANTED LENS WAS DISCARDED AFTER SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7657545 ↗
• InjuryMay 4, 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 ZXT300, +22.0 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE FROM PATIENT¿S LEFT EYE BECAUSE OF THE PATIENT EXPERIENCING UNEXPECTED POST OP REFRACTION. REPORTEDLY, MODEL ZXT300, +24.0 DIOPTER WAS USED AS REPLACEMENT LENS FOR THE PATIENT DUE TO REFRACTIVE ERROR. THERE WAS NO INCISION ENLARGEMENT. PATIENT HAS RECOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7487687 ↗
• InjuryJan 30, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT300 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, BECAUSE OF A MYOPIC ISSUE AND THE VISUAL OUTCOME WAS NOT ACHIEVED. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 20.0. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7229270 ↗
• InjuryDec 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, BECAUSE THE PATIENT WAS UNHAPPY WITH THE READING THAT THE LENS PROVIDED. THERE WAS AN INCISION ENLARGEMENT AND SUTURES USED. THE LENS WAS REPLACED WITH A 3-PIECE LENS, THE MODEL AND TYPE WERE NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7081689 ↗
• InjuryOct 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) . IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE PATIENT HAD SOME RESIDUAL CYLINDER. ALSO, THE GOAL WAS TO TIGHTEN DISTANCE SINCE THE SPHERICAL EQUIVALENT (SE) IS -.5. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY. THE REPLACEMENT LENS WAS THE SAME DIOPTER, BUT DIFFERENT MODEL ZXT375. REPORTEDLY, THE PATIENT IS DOING OKAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6989554 ↗
• MalfunctionAug 1, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE USER NOTICED A BUBBLE ON THE LENS UPON OPENING IT. NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6759086 ↗
• InjuryFeb 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL SYMFONY INTRAOCULAR LENS IMPLANTS. MODEL ZXT 300 WERE IMPLANTED IN BOTH EYES. AFTER IMPLANTATION THE PATIENT EXPERIENCED STARBURSTS IN BOTH EYES. PATIENT DID HAVE 1 DIOPTER OF RESIDUAL ASTIGMATISM IN THE RIGHT (DOMINANT) EYE GIVING UNCORRECTED VISUAL ACUITY (UCVA) OF 20/25 AND 20/20 UCVA IN THE LEFT EYE. PATIENT'S VISION REMAINS THE SAME WITH MINIMAL RESIDUAL CORRECTION IN PLACE (BEST-CORRECTED). PATIENT'S NEAR VISION IS GOOD AT J2 IN BOTH EYES. PATIENT IS HAPPY WITH HER NEAR VISION. THEY EXPLANTED THE ZXT 300 IN THE RIGHT EYE AND REPLACED IT WITH A ZCT 400 TO CORRECT THE RESIDUAL ASTIGMATISM AND HOPEFULLY REDUCE THE DYSPHOTOPSIA. PATIENT IS 20/40 1 DAY POST-OP. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THEY EXPLANTED THE ZXT 300 FROM THE LEFT EYE AND REPLACED IT WITH A ZCT300 +21.5D. NO INCISION ENLARGED AND NO VITRECTOMY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT WILL CAPTURE THE ZXT IOL EXPLANTED FROM THE LEFT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 6300204 ↗