LQJClass II

Lens, Surgical, Laser, Accesssory, Ophthalmic Laser

Ophthalmic · 21 CFR 886.4390

MDR events11All time

Recalls1All time

Registered firms2Currently listed

510(k) clearances13All time

Recent MDR events

11 adverse event reports on file

Event type breakdown

Malfunction8

Other2

Injury1

Most-reported manufacturers

Fisma5 Fisma, Inc.2 Unspecified1 Hgm Medical Laser Systems Inc.1 Rare Earth Medical Inc1 Rare Earth Medical Inc.1 Rare Earth Medical, Inc.1

Recalls

1 recall events for this product code

Alcon Research, Ltd
TerminatedSep 21, 2005
Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegad
Unknown residue noted on suface of flap irrigators incorporated into cusom paks.
Z-1575-05 · View FDA record ↗

Registered firms

2 firms currently registered for this product code

510(k) clearances

13 clearances for this product code