ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received Jul 9, 2026 · Event occurred Jun 2, 2026
Report 3009026057-2026-00031 · MDR key 25765407
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
- Use of Incorrect Control/Treatment Settings
Patient
NA · Unknown
- Visual Impairment
Narrative
Description of Event or Problem
ON (B)(6) 2026, DOCTOR (B)(6) REPORTED TO CAS THAT ON (B)(6) 2026, PROCEDURE ID #(B)(6) RESULTED IN AN OVERCORRECTION POSTOPERATIVELY. SITE IS SEEKING REVIEW.
Additional Manufacturer Narrative
REVIEW OF DATA FROM PROCEDURE #(B)(6) SHOWS AN SIA VALUE OF 0.00D AT 180°, A MANUAL ASTIGMATISM ENTRY OF 3.80D AT 179°, AND A MANUALLY ENTERED SINGLE 60° ARCUATE INCISION AT AN AXIS OF 359°. REFRACTIVE CAPSULORHEXIS WAS ALSO COMPLETED AT AN AXIS OF 179°/359°. IRIS REGISTRATION WAS SUCCESSFUL AND THE SYSTEM COMPLETED THE ARCUATE AND REFRACTIVE CAPSULORHEXIS AS PROGRAMMED. RECOMMEND THE SITE VERIFY THE PRE-OP DATA, NOMOGRAM USED TO CALCULATE ARCUATE LENGTH AND AXIS AND THE SURGERY PLAN WITH THE SURGEON AND COMPARE IT TO THE VALUES ENTERED IN THE SYSTEM TO DETERMINE CAUSE OF REPORTED OVERCORRECTION. SYSTEM FUNCTIONED AS DESIGNED.