ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received Apr 24, 2026 · Event occurred Apr 9, 2026
Report 3009026057-2026-00016 · MDR key 24979922
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
Additional Manufacturer Narrative
REVIEW OF PROCEDURE#: 1709 FILES SHOW A MANUAL ASTIGMATISM ENTRY OF 0.90 @ 7 AND MANUAL ARCUATE ENTRY OF 1 X 70 DEGREE ARCUATE @ 187. THE SYSTEM EXECUTED THE ARCUATE AS PROGRAMMED. REVIEW OF PROCEDURE #1965 SHOW A MANUAL ASTIGMATISM ENTRY OF 0.40 @ 174 AND A MANUAL ARCUATE ENTRY OF 1 X 60 @ 174. THE SYSTEM EXECUTED THE ARCUATE 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. THE SITE IS PLANNING POST OPERATIVE CARE FOR THE PATIENTS, WITH EITHER PROVIDING LASIK OR AN IOL EXCHANGE. NO FURTHER CLINICAL FOLLOW-UP REQUIRED.
Description of Event or Problem
ON (B)(6) 2026, DOCTOR (B)(6) REPORTED TO CAS THAT THEY NOTED PROCEDURE IDS #1709 AND #1965 RESULTED IN AN OVERCORRECTION POSTOPERATIVELY.