TECNIS IOL ZLB00 (REF ZLB00U0080)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 1- PC 6.0MM 8.0D LOW ADD US · Class 3 · Implant
Data updated Oct 13, 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 05050474560437), received between Mar 31, 2017 and Mar 31, 2017 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Code Available1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 31, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT A A ZLB00 8.0 DIOPTER (D) INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT EXPERIENCING SEVERE DISTORTED VISION FOLLOWING THE CATARACT SURGERY. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A 9.5 DIOPTER. THE WAS NO INCISION ENLARGEMENT OR VITRECTOMY REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. THROUGH FOLLOW UP IT WAS CONFIRMED PHYSICIAN PREFORMED THE IOL EXCHANGE DUE TO A MISCALCULATION AND OVERCORRECTION OF THE IOL POWER. ADDITIONALLY, IT WAS LEARNED THAT THE PATIENT'S REFRACTION WAS +1.25 BEST CORRECTED 20/60 AFTER THE ZLB00 8.0 D IOL WAS IMPLANTED. PRIOR TO SURGERY PATIENT'S LEFT EYE (OS) WAS BEST CORRECTED 20/25 WITH -8.25 SPHERE (SPH).
Patient problems: No Code Available; Visual Disturbances
MAUDE report 6450446 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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