InjuryOOE
LENSX LASER SYSTEM
Received Jun 15, 2026
Report 2028159-2026-00858 · MDR key 25498919
Device
Generic name
Ophthalmic Femtosecond Laser
Manufacturer
Alcon Research, Llc - Irvine Technology CenterModel number
550Catalog number
8065998162RP
Lot number
NA
Product problems
- Failure to Cut
Patient
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 PHYSICIAN REPORTED THAT THE ANTERIOR CAPSULE RENTS AND THE CAPSULES HAVE BEEN INCOMPLETE AND REALLY FRAGILE IN THE UNKNOWN EYE OF A PATIENT, DURING REFRACTIVE SURGERY. THE TAGS WERE NASAL AND SUPERIOR.