TECNIS IOL ZMA00 (REF ZMA00U0145)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 3- PIECE 6.0MM 14.5 US · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474536692), received between Feb 24, 2018 and Feb 24, 2018 — classified as 1 injury.
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 Problem1
Patient problems
- Blurred Vision1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD MULTIFOCAL LENSES IMPLANTED BILATERALLY ON (B)(6) 2013. SHE HAS HAD ISSUES EVER SINCE. SHE CANNOT SEE ESPECIALLY AT NIGHT. SHE HAD LASER DONE TO CORRECT FOR ASTIGMATISM ON (B)(6) 2013. SHE REPORTED THAT IT IS BETTER BUT STILL NOT THE BEST AND DESCRIBED HER VISION AS CLOUDY. SHE HAD BILATERAL YAG CAPSULOTOMY DONE ON (B)(6) 2013 AND AGAIN IN THE RIGHT EYE IN 2016 TO TREAT SIGNIFICANT POSTERIOR CAPSULE OPACIFICATION (PCO). THE PATIENT MENTIONED THAT SHE IS WORRIED ABOUT POSTERIOR CHAMBER WEAKENING. THE LAST SURGEON SHE WENT TO SEE (DR. (B)(6)) SUGGESTED AN EXPLANT BUT THE PATIENT WAS CONCERNED ABOUT EXPLANTING THE LENS AFTER THIS MANY YEARS. DURING FOLLOW UP WITH THE DOCTOR HE MENTIONED THAT HE DID NOT NOTICE ANY OPACIFICATION ON THE INTRAOCULAR LENSES, BUT THERE WERE POSTERIOR CAPSULAR OPACITIES. IT WAS MENTIONED THAT THE PATIENT HAD INCREASED BLURRING IN LEFT EYE FOR THE PAST 2 MONTHS. THE DOCTOR NOTICED THAT WHEN HE CHECKED HER EYES THIS MONTH AGAIN, HE NOTICED SIGNIFICANT PCO ON THE RESIDUAL POSTERIOR CAPSULE AFFECTING A LARGE PORTION OF THE RINGS IN THE OPTIC OF THE LENS IN THE LEFT EYE. THE PATIENT IS SEEKING FURTHER OPINION ON IOL EXCHANGE. TH
Patient problems: Blurred Vision; No Code Available
MAUDE report 7294492 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page