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VISCOJECT 1.8 Injector set

Medicel AG · Model LP604350 · UDI-DI 07630055220080

MSS Prescription
10
510(k) clearances
5,344
Adverse events
5
Recalls
41
Facilities

Description

Injectors and cartridges for the injection of intraocular lenses (IOL) into the eye during surgical procedures.

Recalls

DateFirmReason
2020-03-17Rayner Intraocular Lenses LimitedRaySert 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
2017-09-01Aaren Scientific Inc.The recommended storage temperature on the label is incorrect.
2017-04-05Bausch & Lomb Surgical, Inc.Complaints concerning kinked haptics that were occurring during lens delivery.
2016-09-05Alcon Research, Ltd.The intraocular lens could become lodged within the cartridge
2003-08-18Beckman Coulter IncValues 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.