TECNIS IOL ZXT225 (REF ZXT225U180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474605756), received between Nov 28, 2016 and Jun 13, 2019 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIALLY THE CUSTOMER ONLY REPORTED THE ZXT225, 18.0 DIOPTER LENS HAD TO BE REMOVED, AND THE EYE WAS SCRATCHED UPON INSERTION. A FEW WEEKS LATER VIA FOLLOW-UP ON (B)(6) 2019 THE CUSTOMER REPORTED A CAPSULE TEAR OCCURRED. THE LENS WAS REMOVED AND REPLACED WITH IOL MODEL Z9002, 18.0 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED REGARDING THIS EVENT.

  Patient problems: Capsular Bag Tear

  MAUDE report 8694350 ↗
• MalfunctionNov 28, 2018Break; Break

  IT WAS REPORTED WHEN REMOVING ZXT225 18.0 DIOPTER INTRAOCULAR LENS (IOL) FROM PACKAGING THE HAPTIC WAS DISTORTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Patient Involvement

  MAUDE report 8113368 ↗
• InjuryJul 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH TWO TECNIS SYMFONY INTRAOCULAR LENSES (IOL) AND EXPERIENCED PROFOUND STARBURSTS AND HALOS ALMOST IMMEDIATELY AFTER SURGERY. THE PATIENT INDICATED THAT HE CONTINUES TO HAVE SEVERE PROBLEMS WITH NIGHT DRIVING AND THAT HE SEES CONCENTRIC CIRCLES AROUND TRAFFIC LIGHTS RADIATING OUTWARD ABOUT FOUR OR FIVE TIMES THE DIAMETER OF THE LIGHT. HE INDICATED THAT HE SEES LARGE HALOS AROUND STREET LIGHTS, TRAFFIC LIGHTS, THE MOON, IN THE THEATER AND ANY LIGHT IN THE DARK. THE PATIENT ALSO MENTIONED THAT HE SEES VERY DISTRACTING AND LARGE STARBURSTS FROM ONCOMING HEADLIGHTS, SO LARGE THAT THEY SOMETIMES BLOCK OUT MOST OF HIS LANE. THE PATIENT REPORTED THAT HE WAS INVOLVED IN A TRAFFIC ACCIDENT WHERE HE HIT ANOTHER CAR. THE SURGEON PERFORMED A YAG LASER CAPSULOTOMY ON THE LEFT EYE SHORTLY AFTER SURGERY, AS THE PATIENT HAD DEVELOPED A SECONDARY CATARACT/ PCO (POSTERIOR CAPSULE OPACIFICATION). HOWEVER, THE CUSTOMER MENTIONED THAT THE YAG LASER CAPSULOTOMY DID NOT CHANGE ANYTHING. THE PATIENT HAS TRIED YELLOW ANTI-GLARE NIGHT DRIVING GLASSES, BUT THEY HAVE BEEN NOT HELPFUL. THE DOCTOR SUGGESTED A YAG ON THE RIGHT EYE ALTHOUGH HE DID NOT SEE ANY PCO.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7708257 ↗
• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS DISSATISFIED WITH THE ZXT225 INTRAOCULAR LENS (IOL) AND IT WAS EXPLANTED. THE LENS WAS REPLACED WITH A MODEL ZCT225. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7535954 ↗
• InjuryJan 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE PATIENT COMPLAINED OF IMPAIRED VISION/VISUAL DISTURBANCES. ALSO NOTED WAS THE OUTCOME SIGNIFICANTLY INTERFERED WITH ACTIVITIES OF DAILY LIFE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE REPLACEMENT LENS WAS A ZCT225 17.0 DIOPTER IOL. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 7176749 ↗
• InjuryAug 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXPLANT OF A TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL), MODEL ZXT225 18.0 DIOPTER. NO ADDITIONAL INFORMATION PROVIDED.

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

  MAUDE report 6806233 ↗
• InjuryAug 17, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL), MODEL ZXT225 18.0 DIOPTERS, IMPLANTED INTO THE PATIENT'S LEFT EYE ROTATED ABOUT 30° COUNTERCLOCKWISE FROM ITS INTENDED POSITION OF 180°. THE DOCTOR SUCCESSFULLY REPOSITIONED THE IOL TO 180°. IT WAS ALSO REPORTED THAT IT HAS BEEN TWO WEEKS SINCE INITIAL SURGERY AND REPOSITIONING IS STABLE. THE DOCTOR SAID HE THINKS HIS DROPLESS TRIMOXY INJECTIONS MAY BE CAUSING MORE ROTATIONS DUE TO INCREASE POSTERIOR PRESSURE FROM THE INJECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6802781 ↗
• InjuryNov 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO GLARE AND RINGS AROUND LIGHTS, DYSPHOTOPSIA. PATIENT'S VISION WAS GREAT, 20/20 WITHOUT CORRECTION DISTANCE AND J3 NEAR. THE LENS WAS REPLACED WITH A NON AMO LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6130957 ↗