MST MALYUGIN RING SYSTEM
Received May 8, 2013
Report 3019924-2013-00021 · MDR key 3109295
Device
Generic name
Iris Clip, Retractor
Manufacturer
Microsurgical TechnologyModel number
MAL-0001-1Catalog number
MAL-0001
Lot number
051326
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE EVALUATION OF THE DEVICE SHOWED THAT THE RING FRACTURED AT THE GLUE JOINT. THE INSERTER PASSED FUNCTION TESTING. NO CONCLUSIONS CAN BE DRAWN REGARDING THE MALFUNCTION.
Description of Event or Problem
THE FACILITY REPORTED THAT UPON COMPLETION OF THE CATARACT SURGERY THE DOCTOR WAS REMOVING THE MALYUGIN RING FROM THE EYE WHEN THE RING BROKE AT THE GLUE JOINT. THE TING WAS REMOVED AND THERE WAS NO IMPACT TO THE PT.
Remedial action
- Replace