LENSX LASER SYSTEM
Received Apr 29, 2026
Report 2028159-2026-00597 · MDR key 25038599
Device
Generic name
Ophthalmic Femtosecond Laser
Manufacturer
Alcon Lensx, Inc.Model number
550Catalog number
8065998162
Lot number
NA
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Capsular Bag Tear
Narrative
Additional Manufacturer Narrative
H.3., H.6.: INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THE CAPSULAR TEAR IN UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Additional Manufacturer Narrative
CORRECTED INFORMATION PROVIDED IN G.1. AND H.11. PRODUCT MANUFACTURER DETAILS HAVE BEEN UPDATED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).