ENVISTA SIMPLIFEYE INJECTOR
Received Jul 2, 2025 · Event occurred Jan 23, 2025
Report 0001313525-2025-00141 · MDR key 22383163
Device
Generic name
Folders And Injectors, Intraocular Lens (iol)
Manufacturer
Bausch + LombModel number
21987Lot number
2304D8
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
A HOSPITAL REPORTED THAT SCRATCHES WERE NOTICED ON THE INTRAOCULAR LENS (IOL) AFTER IT WAS IMPLANTED IN THE EYE. THE IOL WAS REMOVED INTRAOPERATIVELY AND REPLACED WITH ANOTHER LENS OF THE SAME POWER. THE INCISION WAS ENLARGED TO REMOVE THE IOL AND A SUTURE WAS REQUIRED. AS A RESULT OF THE INCREASED DURATION OF THE SURGERY, AN ADDITIONAL INTRACAMERAL LOCAL ANESTHETIC WAS NECESSARY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT AND THE PATIENT 'S CURRENT CONDITION IS GOOD.
Additional Manufacturer Narrative
ALTHOUGH REQUESTED, THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DID NOT FIND ANY NON-CONFORMITIES OR ANOMALIES 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 ALL THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED.