MST CAPSULE RETRACTOR
Received Mar 26, 2014
Report 3019924-2014-00009 · MDR key 3851286
Device
Generic name
Ophthalmic Retractor
Manufacturer
Microsurgical Technology, Inc.Model number
MCR-0001Catalog number
MCR-0001
Product problems
- Material Fragmentation
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DURING THE COURSE OF INVESTIGATING THIS INCIDENT A SIMILAR ISSUE WAS IDENTIFIED AND WILL BE SUBMITTED ON REPORT NUMBER 3019924-2014-00010.
Description of Event or Problem
DURING CATARACT SURGERY ON A PATIENT WITH LOOSE ZONULES, AN MST CAPSULE RETRACTOR WAS THREADED ONTO A CAPSULOR TENSION RING AND WAS NOT ABLE TO BE REMOVED FROM THE EYE. THE SURGEON CUT THE CAPSULE RETRACTOR CLOSE TO THE PERIPHERY AND TUCKED THE END OF THE RETRACTOR UNDER THE IOL AND REMOVED THE REMAINING PORTION OF THE RETRACTOR. POST-OP THE PATIENT WAS DOING WELL AND HEALING NORMALLY WITH THE PIECE OF RETRACTOR STILL BEHIND THE CENTERED IOL.
Remedial action
- Patient Monitoring