TECNIS IOL ZKU225 (REF ZKU225U220)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC LOW ADD 1-PC 22.0D CYL2.25 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474687653), received between Mar 11, 2021 and May 5, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Discomfort1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS UNHAPPY WITH A TECNIS MULTIFOCAL INTRAOCULAR LENS (IOL) AFTER IT WAS IMPLANTED IN HER RIGHT (OD) EYE. THE LENS WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS WITH THE SAME DIOPTER POWER. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED DURING THE SECONDARY PROCEDURE. REPORTEDLY, THE PATIENT IS DOING FINE POST-EXCHANGE. NO FURTHER INFORMATION PROVIDED.
Patient problems: Discomfort
MAUDE report 11775058 ↗InjuryMar 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN A PATIENT¿S RIGHT EYE ON (B)(6) 2020. WHEN PATIENT RETURNED FOR THE FOLLOW UP VISIT, IT WAS DETERMINED THAT THE IOL HAD DISLOCATED. THE IOL WAS REPOSITIONED ON (B)(6) 2020 WHICH WAS UNSUCCESSFUL AS THE LENS ENDED UP FALLING TO THE BACK OF THE EYE. ON (B)(6) 2020, THE LENS WAS EXPLANTED AND AN ANTERIOR CHAMBER, NON-JOHNSON & JOHNSON LENS WAS USED AS A REPLACEMENT. THE REPLACEMENT LENS IS STILL IN THE PATIENT¿S EYE. THERE WAS NO OTHER SURGICAL INTERVENTIONS REQUIRED AND NO PATIENT INJURY WAS REPORTED. IT WAS INDICATED THAT THE PATIENT¿S VISION IS STILL NOT THAT GOOD. IT WAS NOTED THAT THE EXPLANTED LENS WAS DISCARDED. NO FURTHER INFORMATION WAS REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11467974 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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