ENVISTA SIMPLIFEYE INJECTOR
Received Jul 15, 2025 · Event occurred Mar 28, 2025
Report 0001313525-2025-00150 · MDR key 22508272
Device
Generic name
Folders And Injectors, Intraocular Lens
Manufacturer
Bausch + LombModel number
21987Lot number
2304E9
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Corneal Edema
- Corneal Edema
Narrative
Additional Manufacturer Narrative
THE PRODUCT IS NOT AVAILABLE FOR RETURN. 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 AND DIRECTION FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem
A HOSPITAL REPORTED THAT ON DAY 2, FOLLOWING AN UNCOMPLICATED INTRAOCULAR LENS (IOL) IMPLANTATION THE PATIENT PRESENTED WITH CORNEAL EDEMA. THE EDEMA WAS TREATED WITH DEXAFREE (DEXAMÉTHASON) EYE DROP, INDOCOLLYRE (INDOMETACIN), ODM5 (SODIUM HYALURONATE) EYE DROPS AND GELTIM (TIMOLOL) VIA OCULAR ROUTE. A BROKEN HAPTIC WAS DISCOVERED IN THE ANTERIOR CHAMBER. APPROXIMATELY 11 WEEKS POST IMPLANTATION THE PATIENT WAS REHOSPITALIZED AND A DIFFERENT SURGEON EXPLANTED THE ORIGINAL IOL, REMOVED THE BROKEN HAPTIC AND ANOTHER LENS WAS PLACED IN THE EYE. BEFORE THE ORIGINAL SURGERY, THE VA WAS 5F/10 P5. TWO DAYS POST-SURGERY THE VA WAS: 3/10 P6. THE VA WAS NOT QUANTIFIABLE AT ONE-MONTH POST-SURGERY. NO VA AVAILABLE POST REVISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.