TECNIS IOL ZXT150 (REF ZXT150U275)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474605350), received between Nov 26, 2019 and Jul 20, 2020 — classified as 2 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ZXT150 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT''S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE PATIENT WAS EXPERIENCING HALOS, TUNNEL VISION AND HAD DIFFICULTY FOCUSING AT A DISTANCE AND NEAR WORSENS WITH BRIGHT LIGHTING. ALSO PATIENT COULD NOT DRIVE AT NIGHT DUE TO VISION. THIS WAS A CASE OF REFRACTIVE LENSECTOMY. THERE WERE NO OTHER MEDICAL/SURGICAL INTERVENTIONS REQUIRED. THE REPLACEMENT LENS USED IS A PCB00 MODEL OF 26.5 DIOPTER. THE PATIENT WAS DOING FINE AFTER DISCHARGE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 10299328 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REACHED OUT TO JOHNSON & JOHNSON REQUESTING ASSISTANCE WITH A PATIENT REPORTING DIFFICULTY/COMPLAINING OF ¿DAY TIME GLARE¿ THAT IS RESULTING IN PATIENT SUFFERING WITH DAY TIME DRIVING. A REQUEST AND SUPPORT TO LOOK OVER THE CHARTS IN AN EFFORT TO ASSIST WITH IDENTIFYING CONCERNS AND FINDING A RESOLUTION. ADDITIONAL INFORMATION NOTES STARBURSTS, AND DID NOT GET BETTER WITH ''MIXTURE'' OF DROPS. LENS IMPLANTED (B)(6) 2019; AND DUE TO THE SEVERE GLARE, DISCUSSED POSSIBILITY OF AN INTRAOCULAR LENS (IOL) EXCHANGE TO A TRADITIONAL IOL IN THE FUTURE IF THE GLARE DOES NOT IMPROVE. PILO 1% SENT TO PHARMACY TODAY TO USE QD OU (ONCE A DAY, BOTH EYES). PILOCARPINE HC1 1% DROPS. BOTH EYES / EVERY EVENING STARTED. PATIENT TO RETURN FOR APPOINTMENT 2 WEEKS FOR POST OP SYMFONY/TORIC OPEN CAPSULE GLARE RECHECK WITH THE DOCTOR. POST OP VISIT: OD (RIGHT EYE): SCDVA: (SANS CORRECTED DISTANCE VISUAL ACUITY) 20/25, SCNVA: (SANS CORRECTED NEAR VISUAL ACUITY) 20/20, SCIVA: (SANS CORRECTED INTERMEDIATE VISUAL ACUITY) 20/16. OS (LEFT EYE): SCDVA: 20/25, SCNVA: 20/25, SCIVA 20/20. CONSULTATION WAS PERFORMED AND DISCUSSION IS STILL ONGOING. THE PATIENT COMPLAINS BITTERLY OF GLARE WITH NO OBVIOUS SO

  Patient problems: No Code Available

  MAUDE report 9374049 ↗