MQUClass IIImplant

Ocular Peg

Ophthalmic · 21 CFR 886.3320

MDR events1All time

Recalls1All time

Registered firms5Currently listed

510(k) clearances4All time

Recent MDR events

1 adverse event reports on file

MEDPOR OCULAR SCREW AND ACCESSORIESOct 15, 2010
InjuryPorex Surgical1057129-2010-00016

Event type breakdown

Injury1

Most-reported manufacturers

Porex Surgical1

Recalls

1 recall events for this product code

Integrated Orbital Implants Inc
TerminatedFeb 7, 2007
Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), Model Number 100045
The threads on the threaded sleeve were manufactured with left-handed threads, requiring a modification to the surgical technique for proper insertion. Failure to properly identify the affected components and apply the modified insertion technique will result in an inability to insert the sleeve into the implant.
Z-0396-2007 · View FDA record ↗

Registered firms

5 firms currently registered for this product code

510(k) clearances

4 clearances for this product code