LENSX LASER SYSTEM
Received Jun 24, 2026 · Event occurred May 21, 2026
Report 2028159-2026-00920 · MDR key 25616631
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
Description of Event or Problem
A PHYSICIAN REPORTED THAT A SURGEON OBSERVED A CAPSULAR TEAR IN AN UNKNOWN EYE OF THE PATIENT DURING THE USE OF CAPSULAR TORIC MARKERS. THERE WERE NO SYSTEM PARAMETERS, ALERTS, OR INDICATORS IDENTIFIED THAT WOULD SUGGEST THE TEAR WAS CAUSED OR CONTRIBUTED TO BY THE SYSTEM DURING REFRACTIVE SURGERY. THE SURGERY COMPLETED ON THE SAME DAY. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT ONE INITIAL'S, IN THE UNKNOWN EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.
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. ALCON LENSX (SITE #3008772169) IS NO LONGER OPERATIONAL. LENSX MANUFACTURED PRODUCTS ARE MAINTAINED AND INVESTIGATED BY THE ALCON RESEARCH, LTD. IRVINE TECHNOLOGY CENTER SITE #2028159). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).