EndoSerter-PL

CorneaGen LLC · Model ES-PL · UDI-DI 00855934007485

OTZ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The EndoSerter-PL is a sterile, single use, hand held, manual ophthalmic surgical instrument. It is used to pre-load a processed donor corneal endothelial allograft for storage and transportation to the ophthalmic surgeon and to deliver the allograft into the anterior chamber of the eye during corneal surgery. It is designed to deliver a corneal endothelial allograft into the eye during corneal endothelial keratoplasty. The loading and storage of donor tissue for transport to the surgeon can be performed by any trained eye bank technician. Users of this instrument are experienced ophthalmic surgeons in a healthcare facility or hospital. Under no situation will empty EndoSerter-PL units be supplied directly to surgeons for loading.

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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.