ENVISTA SIMPLIFEYE INJECTOR
Received Oct 15, 2025 · Event occurred Sep 18, 2025
Report 0001313525-2025-00189 · MDR key 23302877
Device
Generic name
Manual Intraocular Lens Injector, Single-use
Manufacturer
Bausch + LombModel number
21987Lot number
2315A1
Product problems
- Crack
- Adverse Event Without Identified Device or Use Problem
- Crack
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Eye Injury
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Eye Injury
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
THE PRODUCT WAS RETURNED; HOWEVER, EVALUATION COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURN.
Additional Manufacturer Narrative
THE HOSPITAL CONFIRMED THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. THE INVESTIGATION OF THIS EVENT IS IN PROGRESS. A REVIEW OF DEVICE HISTORY RECORD (DHR) DID NOT FIND ANY NON-CONFORMITIES OR ANOMALIES RELATED TO THE REPORTED EVENT. 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 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.
Description of Event or Problem
A HOSPITAL REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) A CRACK WAS NOTICED IN THE OPTIC OF THE LENS. THE LENS WAS REMOVED AND RESULTED IN AN IRIS PROLAPSE. THE SURGERY WAS EXTENDED BY 30 MINUTES WITH A BACK UP LENS IMPLANTED AND 3 STITCHES BEING PLACED. DUE TO THE COMPLICATION THE PATIENT HAD TO RETURN TO HAVE AN OZURDEX PLACED AT A LATER TIME.
Additional Manufacturer Narrative
THE HOSPITAL CONFIRMED THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF DEVICE HISTORY RECORD (DHR) DID NOT IDENTIFY ANY ANOMALIES OR NON-CONFORMITIES THAT COULD BE RELATED TO THIS EVENT. 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 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.