M-PORT SI INJECTOR
Received Oct 20, 2015 · Event occurred Nov 20, 2014
Report 0001313525-2015-02890 · MDR key 5160986
Device
Generic name
Intraocular Lens Guide
Manufacturer
Bausch & Lomb IncorporatedModel number
EZ-28Lot number
H46102
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THAT THE TRAILING LENS HAPTIC KINKED. THE INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.
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 THE EXACT ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. HOWEVER IT IS POSSIBLE THAT USER RELATED FACTORS (SUCH AS LOADING OR HANDLING TECHNIQUES) AND/OR PROCEDURAL FACTORS (SUCH AS LENS AND INSERTER INTERACTION) MIGHT HAVE CONTRIBUTED TO THE EVENT.