ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received Mar 4, 2026 · Event occurred Feb 5, 2026
Report 3009026057-2026-00007 · MDR key 24507280
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
- Improper or Incorrect Procedure or Method
- Patient Device Interaction Problem
Patient
NA · Unknown
- Capsular Bag Tear
Narrative
Additional Manufacturer Narrative
REVIEW OF PROCEDURE (B)(6) VIDEO AND IMAGING SHOWS SIGNIFICANT PID DECENTRATION IN THE PID RING AND PATIENT MOVEMENT DURING THE PROCEDURE. THIS WAS VIEWABLE TO THE SURGEON PRIOR TO THE SURGERY. THIS WOULD CAUSE INCOMPLETE OR TAGGED AREAS ON THE CAPSULOTOMY, REQUIRING CAREFUL REMOVAL OF THE CAPSULAR BUTTON DURING THE CATARACT REMOVAL PORTION OF THE PROCEDURE. THE CAPSULAR TEAR LIKELY OCCURRED DURING THE CATARACT REMOVAL PORTION OF THE PROCEDURE AS THERE WAS ~ 3 CLOCK HOURS OF INCOMPLETE CAPSULOTOMY. SYSTEM FUNCTIONED AS DESIGNED. PATIENT RECEIVED A SULCUS IOL DUE TO CAPSULAR BAG INSTABILITY. PO RETINA VISIT WITH DOCTOR SHARED THAT THE PATIENT WAS SENT TO RETINA FOR A VITRECTOMY WITHIN A FEW DAYS OF THE POSTERIOR CAPSULE TEAR, AND AFTER THE RETINAL SURGERY THE PATIENT HAD ISCHEMIC OPTIC NEUROPATHY. PATIENT IS 20/30 NOW BUT WITH SOME LOSS OF CONTRAST. NO FURTHER CLINICAL FOLLOW UP REQUIRED.
Description of Event or Problem
ON 02/06/2026, DOCTOR (B)(6) REPORTED TO CAS THAT ON (B)(6) 2026 DURING PROCEDURE ID (B)(6), THEY EXPERIENCED AN INCOMPLETE CAPSULOTOMY AND RADIAL TEAR.
Additional Manufacturer Narrative
REVIEW OF PROCEDURE # (B)(6) VIDEO AND IMAGING SHOWS SIGNIFICANT PATIENT DECENTRATION IN THE PID RING AND MOVEMENT DURING THE PROCEDURE. THIS WOULD MOST LIKELY LEND ITSELF TO INCOMPLETE OR TAGGED AREAS ON THE CAPSULOTOMY, REQUIRING CAREFUL REMOVAL OF THE CAPSULAR BUTTON DURING THE CATARACT REMOVAL PORTION OF THE PROCEDURE. THE CAPSULAR TEAR MAY HAVE OCCURRED DURING THE CATARACT REMOVAL PORTION OF THE PROCEDURE. A REVIEW OF LOCKING / CENTRATION TECHNIQUE WITH THE PID RING TO AND PID ARM AND BUTTON REMOVAL BEST PRACTICES AFTER AN INCOMPLETE CAPSULOTOMY HAS HAPPENED DUE TO PATIENT MOVEMENT. SYSTEM FUNCTIONED AS DESIGNED. NO FURTHER CLINICAL FOLLOW-UP REQUIRED.
Description of Event or Problem
ON (B)(6) 2026, DOCTOR ((B)(6)) REPORTED TO (B)(6) THAT ON (B)(6) 2026 DURING PROCEDURE ID # (B)(6), THEY EXPERIENCED AN INCOMPLETE CAPSULOTOMY AND RADIAL TEAR.