InjuryMSS
BAUSCH + LOMB IOL INJECTOR
Received Oct 2, 2015 · Event occurred Aug 10, 2015
Report 0001313525-2015-02655 · MDR key 5124860
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
61 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THAT THE LENS WAS IMPLANTED AND REMOVED DUE TO A MIS-LOAD. THE INCISION WAS ENLARGED AND ANOTHER LENS WAS IMPLANTED. SUTURES WERE USED. IN THE SURGEON'S OPINION THE LIKELY CAUSE OF THE EVENT WAS LOADER ERROR.