ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received Apr 24, 2026 · Event occurred Mar 30, 2026
Report 3009026057-2026-00015 · MDR key 24979863
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 ID#2121 SHOWS A MANUAL CYLINDER AND AXIS ENTRY OF 0.30D @ 23 AND MANUAL ENTRY OF A SINGLE 45 DEGREE ARCUATE @ 23. PROCEDURE ID#2287 SHOWS A MANUAL CYLINDER AND AXIS ENTRY OF 0.20D @ 18 AND A MANUAL ENTRY OF A SINGLE 60 DEGREE ARCUATE @ 18. THE SURGEON TABLE USED FOR CALCULATING ARCUATES THAT IS ON THE SYSTEM WAS NOT USED BY THE SITE TO CALCULATE THE ARCUATES, AND THE ASTIGMATISM VALUES AND ARCUATE LENGTH AND AXIS WERE ENTERED INTO THE SYSTEM BY THE SITE. THE SYSTEM TREATED BOTH PROCEDURES AS PROGRAMMED. RECOMMEND THE SITE VERIFY THE PRE-OP DATA AND 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 ON PROCEDURE IDS #2121 AND #2287 RESULTED IN AN OVERCORRECTION POSTOPERATIVELY.