M-PORT SI INJECTOR
Received Sep 30, 2015 · Event occurred Sep 1, 2015
Report 0001313525-2015-02650 · MDR key 5112646
Device
Generic name
Intraocular Lens Guide
Manufacturer
Bausch & Lomb IncorporatedModel number
EZ-28Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
70 YR
- No Known Impact Or Consequence To Patient
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 THE EXACT ROOT CAUSE COULD NOT 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.
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 UPON INSERTION OF THE IOL INTO THE EYE ONE HAPTIC WAS NOTED TO BE BENT. THE INCISION WAS ENLARGED, NO SUTURES NECESSARY. A BACKUP LENS WAS IMPLANTED WITH NO ISSUE. THE PATIENT RECEIVED THE USUAL POST-OP TREATMENT AND THE PROGNOSIS IS VERY GOOD. ACCORDING TO THE PHYSICIAN, LOADING ERROR WAS THE LIKELY CAUSE OF THE EVENT.