inforMED
InjuryHNI

MST CAPSULE RETRACTOR

Received Dec 12, 2017

Report 3019924-2017-00021 · MDR key 7108568

Device

Generic name

Retractor, Ophthalmic

Model number

MCR-0002

Catalog number

MCR-0002

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Vitrectomy
  • Vitrectomy

Narrative

Additional Manufacturer Narrative

A VIDEO PRESENTATION FROM A TRADE SHOW WAS REVIEWED. WHILE REMOVING A HARD CATARACT, CAPSULE RETRACTORS WERE USED TO STABILIZE WEAK ZONULES. DURING SURGERY ONE OF THE CAPSULE RETRACTORS SLIPPED OFF OF THE CAPSULE. AFTER THIS OCCURED A CAPSULE TEAR WAS NOTICED AND A VITRECTOMY WAS REQUIRED. A THREE PIECE LENS WAS USED TO COMPLETE THE SURGERY. NO DEVICE WAS RETURNED FOR EVALUATION.

Description of Event or Problem

DURING CATARACT SURGERY THE SURGEON EXPERIENCED AN ANTERIOR CAPSULE TEAR RESULTING IN A VITRECTOMY.