EnVista SimplifEYE Injector
Received Jul 27, 2026 · Event occurred Jun 25, 2026
Report 0001313525-2026-00105 · MDR key 50005658
Device
Generic name
Manual Intraocular Lens Injector, Single-use
Manufacturer
Bausch + Lomb Inc.Model number
21987Lot number
2304H10
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that during insertion of an intraocular lens (IOL) the lens became stuck and would not implant fully. Unable to remove the lens from the incision, it was enlarged approximately 1.2mm with a keratome and a back up lens was attempted to be implanted. The back up lens became stuck and a Drysdale instrument was used to remove the lens from the injector. However, zonnuals were destroyed. It was placed in the center of the capsule bag and it remains implanted. Surgery was delayed 10 minutes. This report is for the first injector, 3 of 4. Related report numbers 0001313525-2026-00104, 0001313525-2026-00107 and 0001313525-2026-00106.
Additional Manufacturer Narrative
The device is not available for evaluation. The investigation of this event is in progress. A follow-up report will be submitted upon completion of investigation.