ENVISTA SIMPLIFEYE INJECTOR
Received Mar 5, 2025
Report 0001313525-2025-00026 · MDR key 21524865
Device
Generic name
Folders And Injectors, Intraocular Lens
Manufacturer
Bausch + Lomb Inc.Model number
21987Lot number
2315A1
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
REPORTEDLY, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE HAPTIC ON THE IOL BECAME STUCK AND BROKE. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND A STITCH WAS REQUIRED. A BACK UP LENS OF THE SAME MODEL AND DIOPTER WAS SUCCESSFULLY IMPLANTED. THERE WAS NO REPORTED PATIENT IMPACT.
Additional Manufacturer Narrative
THE DEVICE WAS DISCARDED AND THEREFORE NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DID NOT IDENTIFY ANY ANOMALIES OR NONCONFORMITIES THAT COULD BE RELATED TO THIS EVENT. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. BASED ON THE AVAILABLE INFORMATION, USER RELATED FACTORS (SUCH AS LOADING OR HANDLING TECHNIQUES) AND/OR PROCEDURAL FACTORS (SUCH AS LENS AND INSERTER INTERACTION) MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.