TECNIS IOL ZXT300 (REF ZXT300U150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474606289), received between Jun 13, 2017 and Jan 26, 2021 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE HAD SURGERY ON BOTH EYES LAST YEAR. THE LEFT EYE (OS) A ZXT300 WAS IMPLANTED ON (B)(6) 2020 AND THE RIGHT EYE (OD) WAS IMPLANTED ON (B)(6) 2020. HE INDICATED HE ORIGINALLY HAD DRY EYE. WHEN THE PROCEDURES OCCURRED, HE WAS CURED OF HIS DRY EYE. HOWEVER, HE IS CURRENTLY SUFFERING VERY PAINFUL HEADACHES, FEELS LIKE HIS EYES ARE GOING TO EXPLODE, AND HAS DOUBLE VISION. HE IS HAVING PROBLEMS WITH BALANCE AND WALKING. THIS HAS CAUSED HIM TO FALL SEVERAL TIMES DUE TO HIS DOUBLE VISION AND MUST WEAR A CANE TO PREVENT FALLS. AND HE IS HAVING PROBLEMS READING TO UPDATE HIS LICENSING. HIS DOCTOR HAS MENTIONED THAT HIS DRIVING MIGHT BE AFFECTED, DUE TO HIS BAD VISION. HE IS (B)(6) YEARS OLD BUT CURRENTLY EMPLOYED AND IN NEED OF HIS VISION TO IMPROVE TO KEEP DRIVING. HIS ALLERGIST INDICATED HE MIGHT BE ALLERGIC TO THE LENSES. HE HAS SEEN FOUR DIFFERENT DOCTORS AND THEIR OPINIONS HAVE BEEN THAT HE MUST HAVE THE LENSES EXPLANTED HOWEVER THEY HAVE ALSO MENTIONED THAT IT IS A HIGH-RISK PROCEDURE. DOCTOR IS EXPECTING TO EXCHANGE LENSES BECAUSE HE WAS TOLD HIS EYES WERE REJECTING THE LENS. THE EXCHANGE IS SCHEDULED TO REPLACE IT WITH MONO-FOCAL LENSES. ADDITIONA

  Patient problems: Discomfort; Eye Pain; Headache; Hypersensitivity/Allergic reaction; Visual Impairment

  MAUDE report 11230880 ↗
• InjuryJul 22, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) APPEARED TO HAVE ROTATED AND THE SURGEON SUSPECTED IT HAPPENED EARLY ON, ABOUT A WEEK AFTER SURGERY, AS PATIENT SAYS SHE NEVER SAW CLEARLY. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE LENS ROTATED 60-70 DEGREES. THE PATIENT HAD ALSO EXPERIENCED BLURRY VISION. THE LENS REPOSITIONED SUCCESSFULLY AND PATIENT VERY HAPPY NOW. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10310887 ↗
• InjuryJul 6, 2020Unstable; Unstable

  RECEIVED A REPORT FROM A PATIENT INDICATING THAT AFTER HIS IOL IMPLANT IN HIS RIGHT EYE HE EXPERIENCED FLASHES, A GREY FILM AND THE IOL MOVED, ¿GIGGLING¿ IN EYE. PER HIS DOCTOR THE IOL MOVED DUE TO HIS EYE IS LARGER THAN USUAL. PER THE PATIENT, THE DOCTOR SAID HE WILL NEED TO ADD ¿SPACERS¿ TO HOLD THE IOL IN PLACE. THE PATIENT EXPECTED TO BE ABLE TO SEE DISTANCE AND NOT HAVE TO WEAR GLASSES. HOWEVER, HE CANNOT SEE DISTANCE AND IS WEARING GLASSES. HE USED TO BE ABLE TO SEE 10 AHEAD OF HIM AFTER HIS SURGERY. HE WAS PRESCRIBED PREDNISONE AND DICLOFENAC OPHTHALMIC SOLUTION DROPS 3 DAYS BEFORE SURGERY AND CONTINUED TO TAKE THEM AFTER THE SURGERY. HE APPLIED THIS 4 X DAY THE FIRST WEEK, 3X DAY THE SECOND WEEK, AND 2 X DAY THE NEXT 2 WEEKS. HE IS CONSIDERING DOING HIS OTHER EYE. THRU FOLLOW-UP THE CUSTOMER CONFIRMED THAT HE CAN DRIVE DURING THE DAY AND NIGHT. AND HAS GOOD INTERMEDIATE VISION. HOWEVER NEAR AND DISTANCE IS BAD. HE IS WEARING GLASSES. THE PATIENT IS PRESENTLY TAKING PREDNISONE AND DICLOFENAC OPHTHALMIC SOLUTION DROPS. HE DOESN'T SEE THE GREY FILM AS MUCH, BUT THE FLASHES ARE STILL THERE. PER THE PATIENT, THE DOCTOR PLANS ON GOING BACK IN TO ADD SPACERS AND REPOSITION THE LEN

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 10237882 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL STUDY PATIENT HAD BILATERAL TECNIS TORIC SYMFONY INTRAOCULAR LENSES (IOLS) IMPLANTED. THE SUBJECT AT A 1 MONTH VISIT REPORTED EXTREMELY THAT SHE WAS BOTHERED BY STARBURSTS WHILE DRIVING AND MODERATELY BOTHERED BY GLARE RELATED TO SCATTERED LIGHT WHILE DRIVING. IN THE NON-DIRECTED OCULAR VISUAL SYMPTOMS THE SUBJECT COMPLAINED SEVERE STARBURSTS- BOTH EYES (OU). THE MONOCULAR UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) ¿ RIGHT EYE (OD) 20/20; LEFT EYE (OS) 20/20. MONOCULAR BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) ¿ OD 20/15; OS 20/15. HOWEVER, FOR THE 6 MONTH VISIT, BCDVA: 20/20 OD; 20/15 OS. MEDICAL FINDINGS SIGNIFICANT FOR POSTERIOR CAPSULAR OPACIFICATION (PCO) OU. BUT THERE WAS NO YTTRIUM ALUMINUM GARNET (YAG) CAPSULOTOMY PLANNED. ALSO, THE SUBJECT REPORTED A COMPLAINT OF OCULAR VISUAL SYMPTOMS AS EXTREMELY BOTHERED BY STARBURSTS ¿ ¿DRIVE AT NIGHT¿; EXTREMELY BOTHERED BY GLARE RELATED TO SCATTERED LIGHT- ¿DRIVE AT NIGHT¿. IN THE NON-DIRECTED VISUAL SYMPTOMS COMPLAINTS IN THE LEFT EYE INCLUDE BLURRED VISION/DIFFICULTY WITH VISION- NEAR; MILD HALOS; SEVERE STARBURSTS AND DIFFICULTY WITH VISION IN LOW LIGHT. THE SUBJECT DID STATE THE SYMPTOMS SIGNIF

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

  MAUDE report 9924437 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE 6 MONTH UNMASKED STUDY VISIT, THE SUBJECT IS VERY BOTHERED BY HALOS, HAS DIFFICULTY WITH SEVERE NIGHT GLARE, AND DIFFICULTY WITH VISION IN LOW LIGHT AND HAS DIFFICULTY DRIVING AT NIGHT. THE SUBJECT'S SYMPTOMS ARE SIGNIFICANTLY INTERFERING WITH DAILY ACTIVITIES. THE MONOCULAR UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) IS 20/25, MONOCULAR BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) IS 20/20. THERE IS NO INTERVENTION PLANNED AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS LEFT EYE.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9373843 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE 6 MONTH UNMASKED STUDY VISIT, THE SUBJECT IS VERY BOTHERED BY HALOS, HAS DIFFICULTY WITH SEVERE NIGHT GLARE, AND DIFFICULTY WITH VISION IN LOW LIGHT AND HAS DIFFICULTY DRIVING AT NIGHT. THE SUBJECT'S SYMPTOMS ARE SIGNIFICANTLY INTERFERING WITH DAILY ACTIVITIES. THE MONOCULAR UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) IS 20/25, MONOCULAR BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) IS 20/20. THERE IS NO INTERVENTION PLANNED AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS RIGHT EYE.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9373838 ↗
• InjuryJan 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXT300 +15.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE. AN INCISION ENLARGEMENT WAS REQUIRED, BUT NO VITRECTOMY OR SUTURES. THE REPLACEMENT LENS WAS A MODEL ZXT225 +17.0 DIOPTER. PATIENT OUTCOME WAS NOTED AS PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8247012 ↗
• InjurySep 12, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PHYSICIAN IMPLANTED A SYMFONY TORIC LENS INTO THE PATIENT'S EYE USING HELP FROM THE OCULAR RESPONSE ANALYZER (ORA). PRE-OPERATIVE INTRAOCULAR LENS (IOL) CALCULATIONS ESTIMATED A 13.5 DIOPTER LENS AND BETWEEN 300 AND 375. THE ORA ESTIMATED A 15.0 DIOPTER WITH 300, CONFIRMED ALIGNMENT AT 90. THERE WERE SEVERAL MEASUREMENTS TAKEN WITH THE SAME RESULT. THE PHYSICIAN STATED HE HADN¿T SEEN THIS BEFORE. THE PATIENT HAD NO PREVIOUS REFRACTIVE SURGERY. THE PHYSICIAN ENDED UP IMPLANTING A 15.0 DIOPTER ZXT300 LENS ON (B)(6) 2017. HOWEVER, THE PATIENT ENDED UP -2.50 WITH NO ASTIGMATISM POST-OPERATIVELY. THE LENS WAS EXPLANTED ON (B)(6) 2017. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER (13.5). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6860632 ↗
• MalfunctionJun 13, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING HANDLING BUT PRIOR TO INSERTION, LINT PARTICLES WERE OBSERVED ON AN INTRAOCULAR LENS (IOL). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6637799 ↗