CARDINAL HEALTH CAHEYEWEARRecalls & reported problems
Cardinal Health 200, LLC · EYEWEAR, ASSEMBLED FRAME AND LENS · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20885380070621), received between Jun 11, 2025 and Mar 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Shielding Failure” (2 reports).
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
- Shielding Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Shielding Failure
EYEWEAR FRAMES ARE BENT AND HARD TO KEEP ON STAFF. FRAMES DO NOT FIT FACE APPROPRIATELY CAN FALL OFF INTO SURGICAL FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24737230 ↗MalfunctionJun 11, 2025Shielding Failure; Shielding Failure
THE PRODUCT IS TOO SMALL. INCIDENT INVOLVED A SURGEON PERFORMING A PROCEDURE AND THE ITEM POPPED OFF OF HIS HEAD INTO THE STERILE FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22186548 ↗
Other Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) devices
- Symmetry Olsen 607000Aspen Surgical Products, Inc. · Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)1 report
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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