ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received Feb 9, 2026 · Event occurred Jan 21, 2026
Report 3009026057-2026-00003 · MDR key 24293764
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
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Corneal Perforation
- Capsular Bag Tear
Narrative
Description of Event or Problem
ON (B)(6) 2026, WHILE CAS WAS ON-SITE FOR SURGERY SUPPORT, DOCTOR ((B)(6)) REPORTED A POSTERIOR CAPSULAR RUPTURE DURING PROCEDURE ID # (B)(6).
Additional Manufacturer Narrative
REVIEW OF PROCEDURE ID # (B)(6) SHOWS SLIGHT PATIENT MOVEMENT TOWARDS THE END OF THE PROCEDURE BUT ONLY DURING ARCUATE INCISIONS. NOTHING INDICATING CAPSULE COMPROMISE DURING THE FRAGMENTATION PORTION. GAS BUBBLES APPEAR STATIONARY INSIDE THE POSTERIOR OF THE LENS UNTIL PATIENT IS RELEASED. SCHEIMPFLUG IMAGING DOES INDICATE A POSTERIOR SUBCAPSULAR CATARACT WHICH CAN LEND ITSELF TO RISK OF POSTERIOR CAPSULE COMPROMISE DURING HYDRODISECTION AND THE PHACO PORTION OF THE PROCEDURE. SYSTEM FUNCTIONED AS DESIGNED.
Additional Manufacturer Narrative
REVIEW OF PROCEDURE ID # (B)(6) SHOWS SLIGHT PATIENT MOVEMENT TOWARDS THE END OF THE PROCEDURE BUT ONLY DURING ARCUATE INCISIONS. NOTHING INDICATING CAPSULE COMPROMISE DURING THE FRAGMENTATION PORTION. GAS BUBBLES APPEAR STATIONARY INSIDE THE POSTERIOR OF THE LENS UNTIL PATIENT IS RELEASED. SCHEIMPFLUG IMAGING DOES INDICATE A POSTERIOR SUBCAPSULAR CATARACT WHICH CAN LEND ITSELF TO RISK OF POSTERIOR CAPSULE COMPROMISE DURING HYDRODISECTION AND THE PHACO PORTION OF THE PROCEDURE. SYSTEM FUNCTIONED AS DESIGNED. SURGEON STATED PATIENT UNDERWENT A SUCCESSFUL RETINAL PROCEDURE TO REMOVE THE FLOATING LENS. PATIENT IS STATUS POST 1 WEEK RETINAL SURGERY AND RECOVERING AS EXPECTED. NO FURTHER CLINICAL FOLLOW UP IS NEEDED.
Description of Event or Problem
ON (B)(6) 2026, WHILE CAS WAS ON-SITE FOR SURGERY SUPPORT, DOCTOR (AL24035-C21U) REPORTED A POSTERIOR CAPSULAR RUPTURE DURING PROCEDURE ID # (B)(6).