InjuryOOE
ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
Received Jul 6, 2026 · Event occurred Jun 17, 2026
Report 3009026057-2026-00030 · MDR key 25716595
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
Narrative
Additional Manufacturer Narrative
REVIEW OF PROCEDURE#: (B)(6) REVEALS EYE MOVEMENT ON FRAME 27 JUST AS THE ARCUATE INCISION BEGINS AND ARCUATE COMPLETION ON FRAME 34. NO INDICATION OF FULL THICKNESS INCISION IS SEEN. RECOMMEND REVIEW OF ARCUATE INCISION OPENING TECHNIQUE. SYSTEM FUNCTIONED AS DESIGNED. NO FURTHER CLINICAL FOLLOW UP REQUIRED.
Description of Event or Problem
ON (B)(6) 2026, DOCTOR (B)(6) REPORTED TO CAS THAT THEY EXPERIENCED A FULL THICKNESS ARCUATE INCISION DURING PROCEDURE ID#: (B)(6).