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TECNIS IOL ZXR00 (REF ZXR00U0320)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY ERV 32.0D · Class 3 · Implant

All models of TECNIS IOL (1344)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474591837), received between Mar 1, 2018 and Nov 22, 2019 — classified as 3 injuries.

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 18, 2026.

Most reported problems

Device problems

  • Inadequacy of Device Shape and/or Size2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Code Available3
  • Blurred Vision1
  • Visual Impairment1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED ZXR00 32.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019 DUE TO COMPLAINTS OF BLURRY VISION. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING THERE WAS NO COMPLICATIONS SUCH AS CAPSULAR TEAR, NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. IT WAS REPORTED THE ZXR00 32.0 DIOPTER LENS WAS REPLACED WITH A ZXR00 15.0 DIOPTER LENS AND PATIENT OUTCOME WAS REPORTED AS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Patient problems: Blurred Vision; No Code Available

    MAUDE report 9366111 ↗
  • InjurySep 29, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    IT WAS REPORTED THAT A ZXR00 32.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, DUE TO UNEXPECTED POSTOP REFRACTION. THE REPLACEMENT LENS WAS A ZXR00 30.5, A SMALLER DIOPTER LENS. THE ACCOUNT ALSO COMMENTED THAT THE PATIENT HAS A VERY SHORT EYE AND SHE ENDED UP BEING MYOPIC. PATIENT OUTCOME REPORTED AS .5 REFRACTIVE SPHERE, 20/20 SANS CORRECTED AND 20/30 NEAR VISUAL ACUITY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 7921055 ↗
  • InjuryMar 1, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    IT WAS REPORTED THAT A ZXR00 32.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO AN UNEXPECTED POST-OPERATIVE REFRACTION/MYOPIC REFRACTION AND BECAUSE THE PATIENT WAS UNABLE TO SEE SIGNS WELL. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY PERFORMED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 31.0. THERE WAS NO PATIENT INJURY REPORTED AND THE EXPLANTED LENS WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Code Available; Visual Impairment

    MAUDE report 7307395 ↗

Other Extended depth of focus intraocular lens devices

All Extended depth of focus intraocular lens devices →

Sources and updates

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