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Recall Observatory FDA recall evidence

Device product

STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.

Z-1964-2016

May 02, 2016

Class II

Product summary

Firm
Staar Surgical Co.
Event
Event 74067
Status
Terminated
Classification
Class II
Quantity
2,612 units
Official record key
device-enforcement:Z-1964-2016

Official wording

Reason: The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).

Code information: 1281706, 1282812

Distribution pattern: US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).