Hook, Ophthalmic
FDA adverse event reports and recall history for hook, ophthalmic (product code HNQ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 109
- Deaths
- 0
- Injuries
- 63
- Malfunctions
- 46
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-02-04Open, ClassifiedEmployee error
Tecfen Retractable Membrane Polisher, QTPR1267-23
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- 2026-02-04Open, ClassifiedEmployee error
Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- 2025-01-16Open, ClassifiedUnder Investigation by firm
ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A; eye surgery
Reports of various packaging issues that may result in a breach of the sterile barrier.
- Open, ClassifiedUnder Investigation by firm
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
High friction of the slider can cause the device to stick, or not move as intended.
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