ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received May 7, 2026 · Event occurred Apr 14, 2026
Report 3009026057-2026-00019 · MDR key 25116263
Device
Generic name
Ally Adaptive Cataract Treatment System
Manufacturer
Lensar, Inc.Model number
N/ACatalog number
70-00050-001
Lot number
N/A
Product problems
- Device Handling Problem
Patient
NA · Unknown
- Corneal Perforation
Narrative
Additional Manufacturer Narrative
REVIEW OF PROCEDURE ID# (B)(6) VIDEO SHOWS SIGNIFICANT PATIENT MOVEMENT THROUGHOUT THE PROCEDURE AND DURING ARCUATE INCISIONS. PATIENT DOESN'T APPEAR TO BE LOCKED AND THE EYE IS DECENTERED SIGNIFICANTLY. PATIENT MOVEMENT AND DECENTRATION MAY HAVE LED TO POSTERIOR CORNEA BEING COMPROMISED DURING THE ARCUATE PORTION OF THE PROCEDURE. RECOMMEND DISCUSSING PROPER CENTRATION AND LOCKING DURING THE PROCEDURE. THE FULL THICKNESS IS SEALED AND PATIENT IS DOING WELL POST OP. NO FURTHER CLINICAL FOLLOW UP IS REQUIRED.
Description of Event or Problem
ON (B)(6) 2026, DOCTOR (B)(6) REPORTED TO CAS THAT WHILE ATTEMPTING TO INSERT THE INTRAOCULAR LENS ON PROCEDURE ID # (B)(6), HE NOTED THAT VISCOELASTIC BEGAN TO COME OUT OF THE TEMPORAL AK CAUSING A FULL THICKNESS AK.