ENVISTA SIMPLIFEYE INJECTOR
Received Jun 10, 2025 · Event occurred Apr 4, 2025
Report 0001313525-2025-00123 · MDR key 22178141
Device
Generic name
Folders And Injectors, Intraocular Lens (iol)
Manufacturer
Bausch + LombModel number
21987Lot number
2304D7
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Capsular Bag Tear
- Capsular Bag Tear
Narrative
Description of Event or Problem
A HOSPITAL REPORTED THAT DURING AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE PATIENT EYE THE LEADING HAPTIC WAS STRAIGHT AND RUPTURED THE CAPSULAR BAG. THE IOL WAS REMOVED INTRAOPERATIVELY; AN ANTERIOR VITRECTOMY WAS PERFORMED, AND DIFFERENT MODEL LENS WAS SUCCESSFULLY PLACED. PER THE REPORTER THE PATIENT HAD A GOOD VISUAL OUTCOME POST OPERATIVELY.
Additional Manufacturer Narrative
INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.
Additional Manufacturer Narrative
PER THE REPORTER THE INJECTOR IS NOT AVAILABLE FOR RETURN AND EVALUATION. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. BASED ON THE INFORMATION PROVIDED, WE ARE UNABLE TO DETERMINE A ROOT CAUSE. ADDITIONAL INFORMATION: A1,D4,G2,G4,G6,G11,H2,H4,H6,H11.