MST CAPSULE RETRACTORS
Received Mar 15, 2017 · Event occurred Feb 22, 2017
Report 3019924-2017-00004 · MDR key 6407779
Device
Generic name
Retractor, Ophthalmic
Manufacturer
Microsurgical Technology IncModel number
MCR-0001Catalog number
MCR-0001
Lot number
069569
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Eye Injury
- Excessive Tear Production
- Eye Injury
- Excessive Tear Production
Narrative
Additional Manufacturer Narrative
THE PATIENT HAD PREEXISTING CONDITIONS THAT INCLUDED SUBLUXATED CRYSTALLINE LENS AND 360 DEGREES OF ZONULAR DEFICIENCY. THE SURGEON INDICATED THAT THE CAPSULE RETRACTOR WAS ABLE TO STABILIZE THE SUBLUXATED LENS ENOUGH TO COMPLETE REMOVAL OF THE CATARACTOUS LENS HOWEVER DUE TO COMPLETE ZONULAR DEFICIENCY THE RETRACTORS HAD TO BE REPOSITIONED FOR STABILITY RESULTING IN THE CAPSULE TEAR AND SUBSEQUENT VITRECTOMY. AN IOL WAS ABLE TO PLACED VIA SUTURE IN A SECOND SURGERY. DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem
DURING CATARACT SURGERY THE SURGEON EXPERIENCED AN ANTERIOR CAPSULE TEAR RESULTING IN A VITRECTOMY.
Remedial action
- Replace
- Patient Monitoring