TECNIS IOL ZCT300 (REF ZCT300U140)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 14.0D CYL3.00 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 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 05050474553200), received between Sep 22, 2019 and Dec 15, 2020 — 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated1
Patient problems
- No Code Available2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Injury1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT RIGHT EYE. THERE WAS NO ADDITIONAL SURGICAL/MEDICAL INTERVENTION REQUIRED, NO SUTURES PERFORMED. NO PRESCRIPTION WAS GIVEN TO THE PATIENT OUTSIDE OF THE NORMAL POST-OPERATIVE TREATMENT. IT WAS STATED THAT THERE WAS NO LENS TO RETURN. NO FURTHER INFORMATION PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Injury; No Code Available; Visual Impairment
MAUDE report 11009171 ↗InjurySep 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ZCT300 14.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. ZCT300 IOL WAS EXPLANTED (B)(6) 2019 DUE TO COMPLAINT OF RESIDUAL REFRACTIVE ERROR AND REPLACED WITH A ZCT300 17.0 DIOPTER IOL. IT WAS REPORTED THE LENS IS NOT BEING RETURNED AS IT WAS DISCARDED. THROUGH FOLLOW UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING RESIDUAL REFRACTIVE ERROR WAS OBSERVED (B)(6) 2019 1-DAY POST-OP. THERE WAS NO COMPLICATIONS SUCH AS CAPSULAR TEAR, NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, AND NO SUTURE(S). IT WAS REPORTED THE PATIENT IS DOING GREAT POST-LENS EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: No Code Available
MAUDE report 9101410 ↗
Other LENS, INTRAOCULAR, TORIC OPTICS devices
- TECNIS IOL ZCT150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS1 recall7 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS43 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS36 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS32 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS30 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS29 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS21 reports
- TECNIS IOL DIU150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS19 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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