ClearView 3 SBL-3+22.25Recalls & 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
- 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 00844369038393), received between Mar 14, 2025 and May 1, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Toxic Anterior Segment Syndrome (TASS)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2025Use of Device Problem; Use of Device Problem
LENSTEC RECEIVED AN E-MAIL STATING THAT "THE LENS WAS FOUND STUCK TO THE BOTTOM OF THE VIAL." IMPLANT / EXPLANT DATE ON (B)(6) 2025 DUE TO RIP IN THE HAPTIC. A NEW LENS WAS IMPLANTED. THE CART45S CARTRIDGE WAS USED - LOT#: UNKNOWN. THE LENS WAS DISCARDED AT THE FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21941806 ↗InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "PATIENT DEVELOPED TASS SYMPTOMS AFTER SURGERY."
Patient problems: Toxic Anterior Segment Syndrome (TASS)
MAUDE report 21604927 ↗
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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