MICROSTAAR
Received May 29, 2026 · Event occurred Feb 7, 2025
Report 2023826-2026-00923 · MDR key 25336105
Device
Generic name
Intraocular Lens Folders And Injectors
Manufacturer
Staar Surgical CompanyProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
31 YR · Female
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS TEAR/BREAK DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS PATIENT CONTACT AND PATIENT INJURY BUT NO SPECIFIED HARM. LENS IMPLANTED, REMOVED, AND REPLACED INTRAOPERATIVELY. CAUSE OF THE EVENT WAS REPORTED AS OTHER. NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
H6 - HEALTH EFFECT CLINICAL CODE: 4581 - PATIENT INJURY BUT NOT SPECIFIED. H11 - MANUFACTURER NARRATIVE - THERE WAS NO DAMAGE REPORTED TO HAVE BEEN NOTICED DURING THE INSPECTION REQUIRED BY THE DFU PRIOR TO USE AND PREPARATION, WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. CLAIM # (B)(4).