TECNIS IOL ZKU150 (REF ZKU150U195)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC LOW ADD 1-PC 19.5D CYL1.5 · 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 05050474687011), received between Dec 17, 2020 and Nov 18, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- Blurred Vision1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). IOL WAS EXPLANTED IN A SEPARATE SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF TORIC INTOLERANCE AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. THERE WAS NO MEDICAL INTERVENTION. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS FINE. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING REPORTED TORIC INTOLERANCE AS BLURRY VISION AND PATIENT WAS DISSATISFIED. THERE WERE NO COMPLICATIONS, SUCH AS CAPSULAR TEAR, NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision
MAUDE report 12841034 ↗InjuryDec 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO INCORRECT POWER LENS IMPLANTED. IT WAS REPLACED WITH THE SAME MODEL IOL BUT HIGHER DIOPTER POWER (21.0). THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES DONE. PATIENT WELL POST-OP. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 11025355 ↗
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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