ClearView 3 SBL-3+20.5Recalls & reported problems
Lenstec Barbados Inc · Multifocal IOL modified plate, HEMA · Class 3 · Implant
All models of ClearView 3 (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844369038324), received between Aug 27, 2025 and Aug 26, 2026 — classified as 3 injuries, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Visual Disturbances2
- Blurred Vision1
- Iritis1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem
Lenstec received an email stating " IOL exchange due to scratch on lens upon implant".
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 50457758 ↗MalfunctionMay 6, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "HAPTIC BROKE DURING INSERTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25103757 ↗InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "DR. SAYS SHE SAW A CRACK IN THE LENS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24446016 ↗InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LENSTEC RECEIVED AN EMAIL STATING "THAT DUE TO ISSUES WITH THE LENS, REFERRED BY DOCTOR, THE LENS WAS EXPLANTED AND REMOVED DUE TO MECHANICAL COMPLICATIONS OF THE LENS - INITIAL ENCOUNTER. PATIENT INJURY AND SURGICAL INTERVENTION WERE NOTED. ANOTHER LENS OF A DIFFERENT MODEL WAS IMPLANTED SUCCESSFULLY IN THE PATIENT'S EYE."
Patient problems: Iritis; Visual Disturbances
MAUDE report 22904034 ↗
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.
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