M-PORT SI INJECTOR
Received Oct 9, 2015
Report 0001313525-2015-02792 · MDR key 5140802
Device
Generic name
Intraocular Lens Guide
Manufacturer
Bausch & Lomb IncorporatedModel number
EZ-28 DELIVERY DEVICELot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
69 YR
- Capsular Bag Tear
- Vitrectomy
Narrative
Additional Manufacturer Narrative
THE LOT NUMBER OF THE DELIVERY DEVICE WAS NOT PROVIDED, AND THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, A DEVICE HISTORY REVIEW (DHR) AND PRODUCT EVALUATION COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, WE ARE UNABLE TO CONCLUSIVELY DETERMINE A ROOT CAUSE.
Description of Event or Problem
IT WAS REPORTED THAT THE LENS WAS IMPLANTED AND REMOVED DUE TO A BROKEN HAPTIC. THE SURGERY WAS COMPLICATED BY EXTENDED INTRAOPERATIVE TIME TO DEAL WITH CAPSULAR RUPTURE, WHICH ACCORDING TO THE SURGEON WAS INITIALLY PRESENT. THE PATIENT HAS MULTIPLE ISSUES WITH THIS EYE INCLUDING A VITRECTOMY ON (B)(6) 2015. THE DOCTOR BELIEVES THE ROOT CAUSE IS A POSSIBLE LOADING ERROR AS THE LENS CAME OUT OF THE CARTRIDGE WITH A SEVERELY KINKED HAPTIC. A BACKUP LENS WAS IMPLANTED WITHOUT ANY ISSUE. THE PATIENT'S CURRENT PROGNOSIS IS "GOOD IN THAT EYE."