BAUSCH + LOMB IOL INJECTOR
Received Oct 5, 2015 · Event occurred Sep 1, 2015
Report 0001313525-2015-02678 · MDR key 5128988
Device
Generic name
Intraocular Lens Guide
Manufacturer
Bausch & Lomb IncorporatedModel number
INJ100Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
67 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 CURRENT INFORMATION THE EXACT ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. HOWEVER, IT IS LIKELY 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 THE LENS WAS REMOVED WHEN THE HAPTIC RIPPED DURING IMPLANTATION. THE INCISION WAS ENLARGED AND SUTURES WERE NECESSARY. A BACKUP LENS WAS IMPLANTED WITH NO ISSUE. ACCORDING TO THE SURGEON LOADING ERROR WAS THE LIKELY CAUSE OF THE EVENT.