TECNIS IOL ZCT300 (REF ZCT300U280)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 28.0D 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474553484), received between Jan 30, 2017 and Jul 11, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (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 16, 2026.
Most reported problems
Device problems
- Unintended Movement2
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2017Unintended Movement; Unintended Movement
THE INTRAOCULAR LENS (IOL) WAS NOTED TO HAVE ROTATED 14 DEGREES AT THE 6-MONTH POSTOPERATIVE VISIT. THE PROTOCOL DEFINED SLIT LAMP MEASUREMENT WAS 98 DEGREES ON (B)(6) 2017 VS. THE INTENDED OPERATIVE PLACEMENT OF 84 DEGREES ON (B)(6) 2016. THE IOL REMAINS IMPLANTED. NO REPOSITIONING OR FURTHER INTERVENTION IS REQUIRED. NO PATIENT COMPLICATIONS/INJURY. BEST CORRECTED DISTANCE VISUAL ACUITY WAS 20/20 (OD) AND 20/25 (OU) ON (B)(6) 2017. OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE PATIENT IS CURRENTLY DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6704413 ↗InjuryJan 30, 2017Unintended Movement; Unintended Movement
IT WAS REPORTED THAT A TECNIS TORIC MODEL ZCT300 28.0 DIOPTER INTRAOCULAR LENS (IOL) NEEDS TO BE ROTATED BACK INTO POSITION IN A MALE PATIENT¿S RIGHT EYE (OD). THROUGH FOLLOW UP IT WAS LEARNED THE PATIENT IS CURRENTLY ABOUT 1.5 MONTHS POST-OP, PRESENTING WITH TORIC IOL MISALIGNMENT, RESIDUAL ASTIGMATISM, AND DECREASED VISUAL ACUITY. THE PHYSICIAN PLANS TO RE-EXAMINE THE PATIENT TO RE-MEASURE THE CURRENT REFRACTION AND EXACT ORIENTATION OF THE IOL. PRE-OPERATIVE REFRACTION: +4.50 +1.00 X 179. POSTOPERATIVE REFRACTION: -0.75 +1.50 X 005. BEST CORRECTED VISUAL ACUITY (BCVA) 20/40.
Patient problems: No Code Available; Visual Impairment
MAUDE report 6288227 ↗
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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