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BL-Cart™ IOL Delivery Cartridge

AST PRODUCTS, INC. · Model Type D · UDI-DI 10814899027065

MSS Prescription

510(k) clearances

5,389

Adverse events

Recalls

Facilities

Description

The BL-Cart™ IOL Delivery Cartridge is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through a surgical procedure. The cartridge is intended to be used in conjunction with Alcon Monarch® III IOL Delivery System injector. The BL-Cart™ IOL Delivery Cartridge is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.

Recalls

Date	Firm	Reason
2020-03-17	Rayner Intraocular Lenses Limited	RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with an expiry of 2015. In addition to having an expiry of 2015 the LOT numbe
2017-09-01	Aaren Scientific Inc.	The recommended storage temperature on the label is incorrect.
2017-04-05	Bausch & Lomb Surgical, Inc.	Complaints concerning kinked haptics that were occurring during lens delivery.
2016-09-05	Alcon Research, Ltd.	The intraocular lens could become lodged within the cartridge
2003-08-18	Beckman Coulter Inc	Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.