EASY-LOAD LENS DELIVERY SYSTEM
Received Apr 22, 2026 · Event occurred Mar 25, 2026
Report 0001313525-2026-00039 · MDR key 24955895
Device
Generic name
Folders And Injectors, Intraocular Lens (iol)
Manufacturer
Bausch + Lomb Inc.Model number
EZ-24Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
61 YR · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED AND EVALUATED. A BROKEN HAPTIC WHICH APPEARS TO HAVE RIPPED FROM THE IOL WAS RETURNED IN AN UNIDENTIFIED CARTRIDGE TIP. AS A DEVICE LOT NUMBER WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED. THE TREND ANALYSIS, RISK ANALYSIS, AND DIRECTIONS FOR USE ARE 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) MIGHT HAVE CONTRIBUTED TO THE EVENT.
Description of Event or Problem
IT WAS REPORTED THAT DURING INSERTION OF AN INTRAOCULAR LENS (IOL), THE HAPTIC BECAME STUCK IN THE INJECTOR AND WAS AMPUTATED. THE LENS WAS REMOVED AND THE INCISION WAS ENLARGED. A REPLACEMENT IOL OF THE SAME MODEL AND POWER WAS PLACED, AND A SUTURE WAS REQUIRED. THE PATIENT IS EXPECTED TO EXPERIENCE A PROLONGED RECOVERY PERIOD; HOWEVER, THE OVERALL PROGNOSIS IS EXCELLENT.