TECNIS IOL ZLB00 (REF ZLB00U0285)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 1- PC 6.0MM 28.5D LOW ADD US · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 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 05050474560840), received between Nov 9, 2018 and Nov 9, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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
- Inadequacy of Device Shape and/or Size1
Patient problems
- Blurred Vision1
- Halo1
- Vitrectomy1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 9, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT A DOCTOR IS EXCHANGING A ZLB00 INTRAOCULAR LENS (IOL), AS DURING THE POST OP EXAM, AN IOL MALFUNCTION (PATIENT HAVING VISUAL ISSUES) ALONG WITH AN INCORRECT BIOMETRY WAS REPORTED. PATIENT VISUAL ISSUES INCLUDED DECREASED VISION, SHADOWS, STARBURSTS, ALONG WITH BLURRED VISION, HALOS, A -2.00 IN THE LEFT EYE (OS). THE BEST CORRECTED VISUAL ACUITY (BCVA) PRE-OP WAS -20/40, BCVA POST-OP WAS 20/70. FOLLOW UP PROVIDES THE LENS WAS REPLACED WITH A ZLB00 26.5 DIOPTER LENS. THE DOCTOR HAD TO ENLARGE THE INCISION, PUT IN 3 SUTURES AND ALSO DID AN ANTERIOR VITRECTOMY. THE PATIENT WAS NOTED TO BE FINE POST-OP. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Halo; Vitrectomy
MAUDE report 8057706 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page